Wild Yam extract (dioscorea villosa) • USP Natural Progesterone (from soy) • Aloe Barbadensis leaf juice • Cucumber extract (cucumis sativus) • Jojoba seed Oil, (simmondsia chinensis) • Hybrid Sunflower seed Oil (helianthus annus) • Avocado extract (persea gratissima). Other Ingredients: Purified Water, Glyceryl Stearate, Cetyl Alcohol, Glycerin, Sodium Behenoyl Lactylate, Sodium PCA, Sodium Hyaluronate, Hydrolyzed Glycosaminoglycans, Sodium Lactate, Sorbitol, Proline, Tocopheryl Acetate, Disodium EDTA, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben.
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
Below is general information about the effectiveness of the known ingredients contained in the product FemRite Cream. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product FemRite Cream. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when aloe gel is used topically and appropriately. Aloe gel-containing formulations have been safely applied in clinical trials (101,11982,12096,12098,12159,12160,12163,12164,17418)(90123,90124,90127,90128,90129,90131,97320,98816,103305). When included in topical cosmetics, the Cosmetic Ingredient Review Expert Panel concluded that aloe-derived anthraquinone levels should not exceed 50 ppm (90122).
POSSIBLY SAFE ...when aloe gel is used orally and appropriately, short-term. Aloe gel has been safely used in a dose of 15 mL daily for up to 42 days or 100 mL of a 50% solution twice daily for up to 4 weeks (11984,12164). Also, a specific aloe gel complex (Aloe QDM complex, Univera Inc.) has been safely used at a dose of approximately 600 mg daily for up to 8 weeks (90121). ...when aloe extract is used orally and appropriately, short-term. Aloe extract has been used with apparent safety in a dose of 500 mg daily for one month (101579). Also, an aloe extract enriched in aloe sterols has been used with apparent safety in a dose of 500 mg daily for 12 weeks (101577).
POSSIBLY UNSAFE ...when aloe latex is used orally. There is some evidence that anthraquinones in aloe latex are carcinogenic or promote tumor growth, although data are conflicting (6138,16387,16388,91596,91597). In 2002, the US FDA banned the use of aloe latex in laxative products due to the lack of safety data (8229). ...when aloe whole-leaf extract is used orally. Aloe whole-leaf extract that has not been filtered over charcoal still contains anthraquinones. This type of aloe whole-leaf extract is referred to as being "nondecolorized". The International Agency for Research on Cancer has classified this type of aloe whole-leaf extract as a possible human carcinogen (91598,91908). Although filtering aloe whole-leaf extract over charcoal removes the anthraquinones, some animal research suggests that this filtered extract, which is referred to as being "decolorized", may still cause gene mutations (91598). This suggests that constituents besides anthraquinones may be responsible for the carcinogenicity of aloe whole-leaf extract. It should be noted that commercial products that contain aloe whole-leaf extract may be labeled as containing "whole leaf Aloe vera juice" or "aloe juice" (91908).
LIKELY UNSAFE ...when aloe latex is used orally in high doses. Ingesting aloe latex 1 gram daily for several days can cause nephritis, acute kidney failure, and death (8,8961).
CHILDREN: POSSIBLY SAFE
when aloe gel is used topically and appropriately.
Aloe gel-containing formulations have been safely applied in clinical trials (90124,90131).
CHILDREN: POSSIBLY UNSAFE
when aloe latex and aloe whole leaf extracts are used orally in children.
Children younger than 12 years may experience abdominal pain, cramps, and diarrhea (4).
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Anthraquinones present in aloe latex and aloe whole leaf extracts have irritant, cathartic, and possible mutagenic effects (4,16387,16388,90122). There are also anecdotal reports and evidence from animal research that anthraquinones or aloe whole leaf extracts might induce abortion and stimulate menstruation; avoid using (4,8,19,90122).
LACTATION: POSSIBLY UNSAFE
when aloe preparations are used orally.
Cathartic and mutagenic anthraquinones present in aloe latex and aloe whole leaf extracts might pass into milk; avoid using (4,19).
LIKELY SAFE ...when the fruit is consumed in amounts commonly found in foods (668,669,670,671).
POSSIBLY SAFE ...when the oil is applied to the skin topically and appropriately, short-term. Avocado oil in combination with vitamin B12 appears to be safe when used for up to 12 weeks (14909). There is insufficient reliable information available about the safety of avocado for its other uses.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using in amounts exceeding those commonly found in foods.
LIKELY SAFE ...when used in food amounts. Cucumbers are a common food source (103382,103385). ...when the extract, fruit, fruit extract, fruit water, juice, seed extract, and seed oil are used topically and appropriately. These ingredients have been shown to be safely used in cosmetic products in levels of 0.4% to 3% (103382,103395).
POSSIBLY SAFE ...when cucumber extract or cucumber seed extract is used orally and appropriately. A specific cucumber extract (Q-Actin) has been used with apparent safety in doses of up to 10 mg twice daily for 6 months (103385). Cucumber seed extract has been used with apparent safety in doses of up to 500 mg daily for 6 weeks (103386). There isn't enough reliable information to know if other cucumber products are safe to use in amounts greater than those found in food.
PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of cucumber in amounts greater than those found in foods; avoid using.
LIKELY SAFE ...when used topically (6).
LIKELY UNSAFE ...when used orally because it contains 14% erucic acid, which can cause myocardial fibrosis (6); avoid using.
PREGNANCY AND LACTATION: LIKELY SAFE
when used topically for hygienic uses (6).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally (6).
LIKELY SAFE ...when prescription progesterone products are used orally and appropriately. Micronized progesterone (Prometrium) is an FDA-approved prescription product and has been safely used in multiple clinical trials lasting up to 3 years (226,228,1216,1220,1221,1224). ...when prescription progesterone or other prescription products are used intravaginally and appropriately, short-term (1225,2031,2032,2033,2034,103173,103175). Progesterone intravaginal gel (Crinone) is an FDA-approved prescription product and has been safely used in trials lasting up to 3 months (1225,2031,2033,2034,2041). ...when prescription progesterone products are used intramuscularly and appropriately, short-term (227,1218,1225,2034,93742,93748). There is insufficient reliable information available about the safety of any form of supplemental or non-prescription bioidentical progesterone products. Some research has shown that there are large variations in progesterone concentrations in non-prescription progesterone products (108146).
PREGNANCY: LIKELY UNSAFE
when used orally, intramuscularly, intravaginally, or transdermally for purposes other than medically supervised adjunctive treatment for infertility (15).
There is insufficient reliable information available about the safety of any form of supplemental or non-prescription bioidentical progesterone products. Some research has shown that there are large variations in progesterone concentrations in non-prescription progesterone products (108146).
LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally and appropriately in amounts commonly found in foods. When used as a substitute for other dietary oils, the recommended intake of high-oleic acid sunflower oil is 20 grams (1.5 tablespoons) daily (9780,98563). ...when used topically and appropriately, short-term. Sunflower oil has been applied to the skin twice daily for up to 6 weeks (76687). There is insufficient reliable information available about the safety of sunflower oil when used as an oral rinse.
CHILDREN: LIKELY SAFE
when used orally and appropriately in amounts commonly found in foods.
CHILDREN: POSSIBLY SAFE
when applied topically and appropriately, short-term.
Sunflower oil has been applied to the skin of infants daily for up to 2 months (96144,96145,105524,108143). There is insufficient reliable information available about the safety of sunflower oil when used orally in larger amounts as medicine.
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately in amounts commonly found in foods.
There is insufficient reliable information available about the safety of sunflower oil when used in amounts greater than those found in food.
POSSIBLY SAFE ...when used orally. A dose of 50 mg (containing 8 mg diosgenin) has been used with apparent safety for 12 weeks (12,96724). ...when used topically. A wild yam cream has been used with apparent safety for 3 months (10989).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product FemRite Cream. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, aloe gel might increase the risk of bleeding when taken with anticoagulant or antiplatelet drugs.
Details
In vitro research shows that aloe gel can inhibit platelet aggregation. This inhibition was greater than that seen with celecoxib, but less than that seen with aspirin (105501).
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Aloe might increase the risk of hypoglycemia when taken with antidiabetes drugs.
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Theoretically, aloe latex might increase the risk of adverse effects when taken with cardiac glycosides.
Details
Overuse of aloe latex can increase the risk of adverse effects from cardiac glycoside drugs, such as digoxin, due to potassium depletion. Overuse of aloe, along with cardiac glycoside drugs, can increase the risk of toxicity (19).
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Theoretically, aloe latex might increase the risk of hypokalemia when taken with diuretic drugs.
Details
Overuse of aloe latex might compound diuretic-induced potassium loss, increasing the risk of hypokalemia (19).
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Theoretically, aloe latex might increase the risk for fluid and electrolyte loss when taken with stimulant laxatives.
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Theoretically, aloe latex might increase the risk of bleeding when taken with warfarin.
Details
Aloe latex has stimulant laxative effects. In some people aloe latex can cause diarrhea. Diarrhea can increase the effects of warfarin, increase international normalized ratio (INR), and increase the risk of bleeding. Advise patients who take warfarin not to take excessive amounts of aloe vera.
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Avocado may antagonize the anticoagulant effects of warfarin.
Details
Avocado may antagonize the anticoagulant effects of warfarin; however, there has been only one case report of this interaction (667).
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Theoretically, cucumber seed might have additive effects with antidiabetes drugs and may increase the risk of hypoglycemia.
Details
Animal research shows that cucumber seed extract can decrease blood glucose levels (103391). Monitor blood glucose levels closely.
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Theoretically, using estrogen along with progesterone supplements or non-prescription bioidentical progesterone products might alter the effects of estrogen.
Details
Concomitant use of estrogen with prescription progesterone products can cause breast tenderness (228). Also, use of conjugated equine estrogens with oral micronized progesterone in postmenopausal patients seems to blunt the beneficial effects of estrogen on the lipoprotein profile (1216), although it might not affect estrogen-induced reduction in plasma lipoprotein (a) (1217). It is unclear if this interaction would be clinically significant with the doses found in oral or topical progesterone supplements or non-prescription bioidentical products.
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Theoretically, using paclitaxel along with progesterone supplements or non-prescription bioidentical progesterone products might increase paclitaxel levels and adverse effects.
Details
Human research suggests that administering high-dose progesterone intravenously along with paclitaxel can increase plasma levels of paclitaxel without affecting neutrophil and platelet nadir counts (21359). It is unclear if this interaction would be clinically significant with the doses found in oral or topical progesterone supplements or non-prescription bioidentical products.
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Theoretically, sunflower oil might decrease the effectiveness of antidiabetes medications.
Details
A diet using sunflower oil as a fat source can cause increased fasting blood glucose levels in patients with type 2 diabetes (8132). Dose adjustments to diabetes medications might be necessary.
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Theoretically, wild yam might increase or decrease the effects of estrogen.
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Below is general information about the adverse effects of the known ingredients contained in the product FemRite Cream. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Orally and topically, aloe products are generally well tolerated when used in typical doses.
However, oral aloe latex is associated with a greater risk of adverse effects, especially when used in high doses or long-term.
Most Common Adverse Effects:
Orally: Aloe latex may cause abdominal pain, cramps, and diarrhea.
Topically: Burning, erythema, and itching. Contact dermatitis in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Aloe latex is associated with serious adverse effects when taken in high doses or long-term. Cases of acute hepatitis due to a hypersensitivity reaction to aloe leaf extract has been reported.
Dermatologic ...Topically, aloe gel has occasionally been associated with burning (12164,19741,30697,30706), itching (12164,19741,30697), eczema (90122), erythema (19748,30706,90123), contact dermatitis (12163,12164,30695,30736,30737,30738,30740), popular eruption (30732), and urticaria (30712). Also, a case of generalized nummular and popular dermatitis attributed to hypersensitivity has been reported for a 47-year-old male who used aloe leaf gel, both topically and orally, for 4 years (30740).
Endocrine ...A case of severe hypokalemia has been reported for a male breast cancer patient who was undergoing chemotherapy and using aloe vera 1 liter daily orally for 2 weeks. The hypokalemia was attributed to the cathartic effects of aloe and resolved once aloe use was discontinued (30704).
Gastrointestinal
...Orally, aloe latex can cause abdominal pain and cramps.
Long-term use or abuse of aloe latex can cause diarrhea, sometimes with hypokalemia, albuminuria, hematuria, muscle weakness, weight loss, arrhythmia, and pseudomelanosis coli (pigment spots in intestinal mucosa). Pseudomelanosis coli is believed to be harmless, and usually reverses with discontinuation of aloe. It is not directly associated with an increased risk of developing colorectal adenoma or carcinoma (6138). Orally, aloe gel may cause nausea, stomach cramps, and other gastrointestinal complaints in some patients (104174,111921,111663).
Topically, applying aloe gel in the mouth may cause nausea within 5 minutes of application in some patients (90124).
Hematologic ...A case of Henoch-Schonlein purpura, characterized by abdominal pain, purpura, and severe arthralgia, has been reported in a 52-year-old male who drank aloe juice prepared from four to five leaflets for 10 days prior to symptom development (91598).
Hepatic ...Cases of acute hepatitis have been reported after ingestion of aloe leaf extracts for between 3 weeks and 5 years. This is thought to be a hypersensitivity reaction (15567,15569,16386,17419,90126,91598). A case of acute hepatitis has also been reported for a 45-year-old female who drank two ounces of Euforia juice (Nuverus International), a product containing green tea, noni, goji, and aloe, daily for one month (90125). However, one small clinical trial in healthy individuals shows that taking aloe gel 2 ounces twice daily for 60 days does not impair liver function (104174).
Renal ...Orally, aloe latex can cause hemorrhagic gastritis, nephritis, and acute kidney failure following prolonged use of high doses (1 gram daily or more) (8961).
General
...Orally, avocado has been generally well tolerated in clinical research.
Most Common Adverse Effects:
Topically: A cream containing avocado oil in combination with vitamin B12 can cause itching.
Serious Adverse Effects (Rare):
Orally: Avocado may lead to allergic cross-sensitivity in latex sensitive patients. While rare, avocado can cause acute food protein-induced enterocolitis syndrome (FPIES), a food hypersensitivity reaction characterized by excessive vomiting and diarrhea.
Dermatologic ...Topically, a cream containing avocado oil in combination with vitamin B12 can cause itching when applied initially, but itching appears to diminish with continued use (14909).
Gastrointestinal ...Orally, avocado can cause acute food protein-induced enterocolitis syndrome (FPIES). This is a rare, delayed, non-IgE-mediated gastrointestinal food hypersensitivity reaction most often reported in infants and young children. Symptoms of FPIES include excessive vomiting within 1-4 hours of avocado consumption and diarrhea. Treatment is generally supportive in nature, including oral or intravenous rehydration, along with avoidance of avocado (100938).
Immunologic ...Orally, avocado may lead to type I hypersensitivity reactions in people who are allergic to latex (6197,7853,25216,33248,33253,33254). While rare, avocado can also cause acute food protein-induced enterocolitis syndrome (FPIES). This is a delayed, non-IgE-mediated gastrointestinal food hypersensitivity reaction most often reported in infants and young children. Symptoms of FPIES include excessive vomiting within 1-4 hours of avocado consumption and diarrhea. Many infants and children who experience FPIES after eating avocado will have the same reaction to other foods, such as milk, oat, and rice (100938).
General
...Orally, cucumber is well tolerated in food amounts.
Cucumber extract and seed extract also seem to be well tolerated. Topically, the extract, fruit, fruit extract, fruit water, juice, seed extract, and seed oil of cucumber are well tolerated.
Most Common Adverse Effects:
Topically: Allergic eczema, erythema, irritation.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis.
Dermatologic ...Topically, mild redness and irritation have occurred rarely (103382).
Immunologic
...Orally, anaphylaxis with dizziness, vomiting, trouble breathing, and itching, occurring 5 minutes after eating a partially peeled cucumber, has been reported in a 76-year-old woman (103382,103384).
Topically, allergic eczema related to exposure to cucumber leaves and stems has been reported in a greenhouse worker (103382,103393).
General ...Side effects of jojoba are mainly limited to contact dermatitis and gastrointestinal concerns in animals fed large amounts of jojoba meal.
Dermatologic ...Contact dermatitis to jojoba oil has been described in case reports (57197,57186).
Endocrine ...Levels of plasma growth hormone and thyroxine increased and levels of plasma insulin-like growth factor-I and triiodothyronine decreased in animals fed diets of 4% jojoba meal (57195).
Gastrointestinal ...In animals fed jojoba oil for four weeks 2-9% of diet), necropsy and histopathological evaluation revealed an apparent distension of the small intestine and marked intestinal changes characterized by massive vacuolization and lipid deposition in the enterocytes, accompanied by distension of the villi and an increased cell turnover of small intestinal cells (57189).
Genitourinary ...In broiler breeding females fed jojoba meal, the size of the eggs laid were smaller and the overall production rate was lower than birds not fed jojoba (57164). Ovary and oviduct weights were also reduced. In female rats fed defatted jojoba meal or pure simmondsin, the number of corpora lutea on gestation day 16 as reduced, and this was thought to be due to decreased food intake in this group (57199). Fetal and placental weights were also reduced in these groups.
Hematologic ...In animals fed jojoba oil for four weeks 2-9% of diet), there was a dose related increase in white blood cell count (57189).
General
...Overall, prescription forms of progesterone are generally well tolerated when used as prescribed.
It is unclear how the progesterone found in supplemental or non-prescription bioidentical hormone products may alter the occurrence and likelihood of these adverse effects.
Most Common Adverse Effects:
Orally: Acne, allergic skin rash, altered menstrual cycles, appetite changes, breast discomfort, breast enlargement, depression, fatigue, fever, fluid retention, gastrointestinal disturbances, headache, insomnia, irregular bleeding, premenstrual syndrome (PMS)-like symptoms, and weight gain.
Topically: Vaginal spotting.
Dermatologic ...Orally, progesterone can cause fluid retention and edema, acne, allergic skin rashes, and hives (506,1224). When given intravenously, phlebitis has occurred at the injection site (93742,93748).
Endocrine ...Orally, progesterone can cause fever, breast discomfort or enlargement, and PMS-like symptoms (506,1224).
Gastrointestinal ...Orally, progesterone can cause gastrointestinal (GI) disturbances and changes in appetite (506,1224).
Genitourinary ...Orally, progesterone can cause altered menstrual cycles and irregular bleeding (506,1224,69986). Topically, progesterone can cause vaginal spotting (224).
Hepatic ...Progesterone can cause hepatotoxicity with elevated liver function tests (275). There is also some concern that autoimmune progesterone dermatitis (APD) can cause adverse hepatic effects, possibly due to the presence of progesterone receptors on cholangiocytes and hepatocytes. In one case report, a female patient treated with progesterone for menorrhagia for 1 week presented with APD characterized by cholestatic hepatitis and cutaneous inflammation (105866).
Immunologic ...Orally, progesterone can cause allergic skin rashes and hives (506,1224). In one case, a female patient treated with progesterone for menorrhagia presented after only 1 week with refractory jaundice due to cholestatic hepatitis and cutaneous inflammation in the form of erythematous, slightly blanchable plaques on the legs, upper arms, and abdomen. Autoimmune progesterone dermatitis (APD) was confirmed and localization of APD-related inflammation in the hepatobiliary system is thought to have been the reason for cholestatic hepatitis (105866).
Neurologic/CNS ...Orally, progesterone can cause fatigue, drowsiness or insomnia, and headache (506,1224,2032,69848,69986). Topically, progesterone can cause headache (108147). When given intramuscularly, progesterone can produce mild sedative effects or feelings of sluggishness (69815).
Psychiatric ...Orally, progesterone can cause depression or make depression worse (506,1224,69944).
Pulmonary/Respiratory ...There are case reports of hypersensitivity, resulting in pulmonary compromise, to the oil vehicle in progesterone-in-oil products (69847,69886).
Other ...Orally, progesterone can cause weight gain (506,1224).
General
...Orally and topically, sunflower oil is well tolerated.
Serious Adverse Effects (Rare):
Orally: Allergic reactions in sensitive individuals have been reported.
Immunologic ...Orally, sunflower oil can cause an allergic reaction in individuals sensitive to the Asteraceae/Compositae family. Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs. However, the protein content of sunflower oil is very low. In one case report, an allergic response to sunflower oil did not occur despite presenting with severe allergy and anaphylaxis to sunflower seed (108140).
General
...Orally, wild yam is generally well tolerated.
Most Common Adverse Effects:
Orally: Fever, headache, upset stomach, and vomiting.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis.
Gastrointestinal ...Orally, wild yam can cause upset stomach and vomiting, especially at higher doses (12,86450).
Hematologic ...In one case report, a 55-year-old female with protein S deficiency and systemic lupus erythematosus (SLE) had temporary vision loss in the left eye from hemiretinal vein thrombosis 3 days after taking a combination phytoestrogen product containing wild yam 276 mg, dong quai 100 mg, red clover 250 mg, and black cohosh 250 mg (13155). It is unclear if wild yam contributed to this event.
Immunologic ...There are three case reports of anaphylaxis after ingestion of cooked wild yam (96722).
Neurologic/CNS ...Orally, wild yam can cause headache and fever, especially at higher doses (86450).