Lavender (lavendula angustifolia) • Cedarwood (cedrus atlantica) • Roman Chamomile (chamaemeium nobile) • Coconut Oil .
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Below is general information about the effectiveness of the known ingredients contained in the product Tranquil Roll On. 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
There is insufficient reliable information available about the effectiveness of Eastern red cedar.
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 Tranquil Roll On. 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 used orally in food amounts. Coconut oil can be safely consumed as a component of the diet (12361,17935,94452,106494). However, coconut oil should not be considered a healthy alternative to other saturated fats (94453,94643). Coconut oil contains more saturated fat than animal based fats, including lard and butter (94643). Therefore, like all saturated fats, coconut oil should be used in moderation (94453,94643). ...when used topically and appropriately. Commercial products containing coconut oil in concentrations up to 100% have been used with apparent safety. However, most research has used commercial products with concentrations up to 70% (12356,17936,17941).
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts, short-term. Taking coconut oil up to 10 mL orally two or three times daily for up to 12 weeks has been used with apparent safety in clinical research (17938,17942,90615,106493).
CHILDREN: POSSIBLY SAFE
when used topically and appropriately, short-term.
Coconut oil has been used with apparent safety in children and neonates for about one month (13483,17937,90614,90616,96204,101873). There is insufficient reliable information available about the safety of coconut oil when taken orally in children.
PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of using coconut oil in medicinal amounts during pregnancy or lactation.
Coconut oil ingestion increases the amount of lauric acid in breast milk within 10 hours. This indicates that fatty acids from coconut oil are rapidly transferred into human breast milk following oral intake (14086). The impact of this increase in lauric acid on nursing infants is not known.
POSSIBLY UNSAFE ...when used orally in large amounts (exact dose not specified). Overdose of Eastern red cedar essential oil has been associated with vomiting, convulsions, coma, and fatality (12). There is insufficient reliable information available about the safety of Eastern red cedar when used orally in smaller amounts or when applied topically.
PREGNANCY: LIKELY UNSAFE
when used orally.
Eastern red cedar is contraindicated in pregnancy due to reports of abortifacient activity. The specific part or dose of Eastern red cedar associated with its abortifacient activity is unclear (12); avoid using.
LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Lavender has Generally Recognized as Safe (GRAS) status for food use in the US (4912).
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts (9792). In clinical research, a specific product containing lavender oil (Silexan, Dr Willmar Schwabe GmbH & Co. KG) has been used safely at doses of 80-160 mg daily for up to 10 weeks (58077,58080,58098,97257). Powdered dried lavender flowers 500 mg twice daily has also been used with apparent safety for up to 8 weeks (97256). ...when used topically and appropriately. Lavender oil has been used safely for up to 7 months in adults (5177,109858,109865). ...when the essential oil is inhaled as a part of aromatherapy. Clinical studies have used lavender oil aromatherapy with apparent safety for up to 12 weeks (7107,12213,16393,16394,95634,103062,103063,103065,103068).
CHILDREN: POSSIBLY SAFE
when the essential oil is inhaled as a part of aromatherapy.
Clinical studies have used lavender oil aromatherapy with apparent safety in single doses for up to 2 minutes (109868).
CHILDREN: POSSIBLY UNSAFE
when applied topically in males.
Anecdotal reports suggest that applying topical products containing lavender oil to prepubertal males may result in gynecomastia in some cases (15254,95643). Products with a higher concentration of lavender oil and more frequent applications might be more likely to result in gynecomastia.
PREGNANCY AND LACTATION:
Insufficient reliable evidence available.
Preliminary clinical research shows that lavender essential oil can be inhaled during labor, with no apparent adverse outcomes in the infants (95633). Although this study suggests safety, high quality assessment of safety has not been conducted.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Roman chamomile has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when used topically as a 2% gel for up to 4 weeks (107369). ...when the essential oil is inhaled or used topically as aromatherapy (7107). There is insufficient reliable information available about the safety of Roman chamomile when used orally in amounts greater than those found in foods.
PREGNANCY: LIKELY UNSAFE
when used orally in medicinal amounts.
Roman chamomile is believed to be an abortifacient (4). Some population research has found a possible link between the use of Roman chamomile and an increased incidence of reduced birth weight, threatened miscarriage, and preterm labor (97292). There is insufficient reliable information available about the safety of the topical use of Roman chamomile during pregnancy; avoid using.
LACTATION:
Insufficient reliable information available; avoid using (4).
Below is general information about the interactions of the known ingredients contained in the product Tranquil Roll On. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
In mice and rats given hexobarbital or pentobarbital, sleep time is reduced and metabolism of the drug is increased when they inhale essential oil vapor from Eastern red cedar wood chips in their bedding (19,98802). Cedrol and cedrene in the essential oil are reported to induce liver microsomal enzymes (19). Theoretically, inhaling Eastern red cedar wood fragrance might reduce the efficacy of hexobarbital or pentobarbital in humans.
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Theoretically, lavender might potentiate the therapeutic effects and adverse effects of CNS depressants.
 Details
Laboratory research suggests that lavender has sedative effects (7). However, clinical studies in patients taking oral lavender oil (Silexan) 160 mg for 10 weeks or taking lavender flower powder 1 gram daily for 2 months have not reported side effects of drowsiness, sedation, or sleepiness (97256,103061). There is still some concern that higher doses or different preparations of lavender might have additive effects with CNS depressant medications.
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Below is general information about the adverse effects of the known ingredients contained in the product Tranquil Roll On. 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, coconut oil is generally well tolerated.
Most Common Adverse Effects:
Orally: Increased cholesterol levels.
Serious Adverse Effects (Rare):
All routes of administration: Allergic reactions, including anaphylaxis, in sensitive individuals.
Cardiovascular ...Due to its high saturated fat content, there has been some speculation that consuming coconut oil might increase cholesterol levels and the risk of cardiovascular disease. Several population and clinical studies have found that consuming coconut oil increases total cholesterol, high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol in some patients (12361,14407,17935,17940,94451,94452,99103,101877,101879,106489,106494). In patients with normal to high cholesterol levels, consuming a daily diet providing 30% to 36% of calories from fat, of which 46% to 66% is from coconut oil, for 4-12 weeks increases total cholesterol by about 12-15 mg/dL, low-density lipoprotein (LDL) cholesterol by about 9-12 mg/dL, and HDL cholesterol by 3-6 mg/dL when compared to a diet containing vegetable oils, especially those rich in polyunsaturated fatty acids (17935,94451,94452,101877,106489). In some cases, these cholesterol effects are similar to those seen in patients consuming a similar diet containing butter or beef fat (12361,17935,94451,99103,101879). Despite the potential effects of coconut oil on cholesterol levels, population research has not found an association with coconut oil consumption and risk of adverse cardiovascular events such as myocardial infarction or angina (14407,96205). Advise patients not to rely on coconut oil as a "healthy" alternative to other saturated fats.
Dermatologic ...In one case report, a 6-year-old child developed urticaria and hives from applying coconut oil to the skin. The child had been exposed to coconut oil consistently since 2 weeks of age, indicating sensitization over the course of regular exposure (95806). In clinical research, one patient reported localized pruritus immediately after applying a combination of coconut oil, anise oil, and ylang ylang (13483). It is unclear if this event was due to coconut oil, other ingredients, or the combination. Also, it is possible that this was an idiosyncratic event.
Gastrointestinal ...Orally, diarrhea and gastroenteritis have been reported rarely (101877).
Hepatic ...Orally, taking virgin coconut oil in the diet for 28 days modestly increased levels of liver enzymes in patients with coronavirus disease 2019 (COVID-19). However, it is unclear if this was due to the coconut oil or to the illness (107664).
Immunologic
...Several cases of allergic reactions have been reported for patients who consumed coconut fruit.
In some of the cases, the patients were previously diagnosed with sensitivity to other tree nuts, including peanuts, so cross-sensitivity is suspected. In a separate case report, a 17-year-old male was found to be sensitized to both coconut and buckwheat, indicating a possible cross-sensitivity between the two allergens (95808). In other cases, the patients did not show sensitivity to any other allergens, so the patients were considered to have a single allergy to coconut fruit (12359,12360).
Because coconut oil is derived from coconut fruit, ingestion of coconut oil may theoretically cause allergic reactions in patients with confirmed allergy to coconut fruit. In one case report, a 6-year-old child who had previously experienced urticaria and hives from applying coconut oil to the skin experienced throat swelling and anaphylaxis after eating food containing coconut, indicating a sensitivity to both the fruit and the oil via both topical application and ingestion (95806). However, allergic reactions to coconut appear to occur significantly less often than allergies to other food items such as wheat, milk, soy, or peanut (14408).
General ...Orally, overdose of Eastern red cedar oil might cause burning in the stomach, vomiting, convulsions, coma, and death (12). Topically, Eastern red cedar oil might cause local allergic reactions and irritation; however, several clinical assessments of safety show that applying Eastern red cedar oil topically does not cause skin sensitization or irritation (11,98802).
Dermatologic ...Eastern red cedar oil might cause local allergic reactions and irritation when used topically; however, sevearl clinical assessments of safety show that applying Eastern red cedar oil topically does not cause skin sensitization or irritation(11,98802).
Gastrointestinal ...Orally, overdose of Eastern red cedar oil (dose not specified) might cause burning in the stomach and vomiting (12).
Neurologic/CNS ...Orally, overdose of Eastern red cedar oil (dose not specified) might cause convulsions, coma, and death (12).
General
...Orally, lavender is well tolerated in food amounts and seems to be well tolerated in larger amounts.
Topically, lavender oil seems to be well tolerated.
Most Common Adverse Effects:
Orally: Breath odor, constipation, diarrhea, dyspepsia, eructation, headache, and nausea.
Topically: Allergic contact dermatitis (with lavender oil).
Serious Adverse Effects (Rare):
Topically: Cases of gynecomastia have been reported in prepubertal males using lavender oil.
Cardiovascular ...Orally, a specific lavender oil ingredient (Silexan) has been associated with palpitations (103061).
Endocrine ...Topical products containing lavender oil alone, including a product referred to as agua de violetas, or in combination with tea tree oil have been linked to at least six cases of gynecomastia when used in prepubertal males. In each case, gynecomastia resolved when the lavender oil products were discontinued. It is thought that the estrogenic and antiandrogenic activity of lavender oil and tea tree oil resulted in gynecomastia in these cases (15254,95643).
Gastrointestinal ...Orally, lavender oil, including a specific lavender oil ingredient KG), may cause gastrointestinal disturbance, including dyspepsia, diarrhea, breath odor, eructation, and nausea (58077,58080,58098,93004,103061). Tincture of lavender has been linked to cases of constipation and increased appetite; however, it is unknown if this occurred at a greater rate than with placebo (9792).
Immunologic ...Topically, use of lavender oil, such as in personal care products, might cause allergic contact dermatitis in some patients (6,101728). There have been numerous case reports of allergic contact dermatitis and eczema linked to lavender oil exposure from shampoos, lotions, fragrances, or direct application of oil to pillows (10031,58043,58109,58120,101728).
Neurologic/CNS ...Orally, lavender flower powder, tincture of lavender containing 50% alcohol, and a specific lavender oil ingredient (Silexan) have been linked to headache (9792,103061,109860). Headache has also been reported rarely following lavender oil aromatherapy (109860).
Pulmonary/Respiratory ...In one case report, a 34-year-old Japanese female presented with complaints of dyspnea, cough, and fever 2 weeks after initiating lavender essential oil therapy via humidifier. The patient had an oxygen saturation of 88% and was diagnosed with acute eosinophilic pneumonia. Symptoms improved after a course of corticosteroids and discontinuation of aromatherapy (109979).
General
...Roman chamomile is generally well tolerated.
Most Common Adverse Effects:
Topically: Allergic skin reactions.
Dermatologic ...Topically, Roman chamomile can cause contact dermatitis (4,567,97292). Allergic skin reactions can occur in up to 20% of individuals exposed to Roman chamomile (19). Multiple case reports have described the development of topical allergic reactions, including eczema and rash, with the use of cleaning products and cosmetics containing chamomile oil or chamomile extract (97292). In one case report, a 55-year-old man experienced disseminated erythroderma with itchy, scaly lesions after non-contact exposure to an area containing many plant varieties. Patch testing confirmed the presence of allergenicity to Roman chamomile (97292).
Gastrointestinal ...Orally, large amounts of Roman chamomile might cause vomiting, although data are conflicting (11,12).
Immunologic ...Allergic skin reactions can occur in up to 20% of individuals exposed to Roman chamomile (19). Cross-sensitivity can occur in individuals with sensitivity to the Asteraceae/Compositae family (19,97292). Multiple case reports have described the development of topical and respiratory allergic reactions with the use of cleaning products and cosmetics containing chamomile oil or chamomile extract (97292).
Pulmonary/Respiratory ...A case report describes the development of cough and rhinitis in a 20-year-old female after exposure to chamomile-scented toilet paper. Skin prick testing confirmed the presence of allergenicity to the toilet paper product (97292).
