Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR)
Aidance Skincare & Topical Solutions, LLC
OTC DRUG
Skin Protectant For the temporary relief of local itching and discomfort in the perianal area, associated with anorectal disorders. Temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues. Temporarily protects irritated areas. Temporarily relieves burning.
OTC monograph final
TERRASIL FISSURES FORMULA- COCOA BUTTER OINTMENT AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they_ _comply with applicable regulations and policies. FDA has not evaluated whether this product complies._ ---------- DRUG FACTS ACTIVE INGREDIENT Cocoa Butter 50% PURPOS E Skin Protectant US ES For the temporary relief of local itching and discomfort in the perianal area, associated with anorectal disorders. Temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues. Temporarily protects irritated areas. Temporarily relieves burning. WARNINGS FOR EXTERNAL AND/OR INTRARECTAL USE ONLY. WHEN USING THIS PRODUCT do not exceed the recommended daily dosage unless directed by a doctor. STOP USE AND ASK A DOCTOR IF - bleeding occurs - condition worsens or does not improve within 7 days. IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or call a Poison Control Center right away. DIRECTIONS Adults: If practical, cleanse the affected area before use. Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement. Regular use provides continual therapy for relief of symptoms. Children under 12 years of age: ask a doctor. INACTIVE INGREDIENTS beeswax (organic), bentonite (volcanic clay), calendula, chamomile, jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, tea tree oil, zinc oxide. PRINCIPAL DISPLAY PANEL - 14G LABEL TERRASIL with Activated Minerals FISSURES FORMULA Coats. Soothes. Protects. TERRASIL FISSURES FORMULA cocoa butter ointment PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:249 0 9 -118 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH CO CO A BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER 50 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT N Läs hela dokumentet