Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
Delsam Pharma Llc
TOPICAL
OTC DRUG
External analgesic / Anti-itch Skin protectant / Anorectal astringent A moisture barrier that prevents & helps heal skin irritation from: • urine • diarrhea • perspiration • fistula drainage • feeding tube site leakage • wound drainage (peri-wound skin) • minor burns • cuts • scrapes • itching
OTC monograph final
MENTHOL AND ZINC OXIDE- MENTHOL, ZINC OXIDE OINTMENT DELSAM PHARMA 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._ ---------- MENTHOL AND ZINC OXIDE OINTMENT DRUG FACTS _ACTIVE INGREDIENTS:_ Menthol 0.44% Zinc Oxide 20.6% _PURPOSE_ External analgesic / Anti-itch Skin protectant / Anorectal astringent _USES:_ A moisture barrier that prevents & helps heal skin irritation from: • urine • diarrhea • perspiration • fistula drainage • feeding tube site leakage • wound drainage (peri-wound skin) • minor burns • cuts • scrapes • itching _WARNINGS:_ _FOR EXTERNAL USE ONLY _ • Not for deep or puncture wounds • Avoid contact with eyes • If condition worsens or does not improve within 7 days, consult a doctor. • Keep out of reach of children • In case of accidental ingestion contact a physician or poison control center immediately _DIRECTIONS:_ Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Menthol and Zinc Oxide Ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection. _INACTIVE INGREDIENTS:_ calamine, cholorothymol, glycerin, lanolin, phenol, sodium bicarbonate, and thymol in a suitable ointment base _OTHER INFORMATION:_ Store at room temperature 15° -30°C, (59° -86°F) _QUESTIONS OR COMMENTS?_ 1-866-826-1306 between 9 am and 4 pm EST, Monday- Friday. *COMPARE TO THE ACTIVE INGREDIENT IN CALMOSETINE OINTMENT MULTIPURPOSE MOISTURE BARRIER PROTECTS, SOOTHES, HELPS PROMOTE HEALING TEMPORARILY RELIVES DISCOMFORT & ITCHING LONG-LASTING PROTECTION Distributed by: DELSAM PHARMA LLC Bronx, Newyork 10467. PACKAGING ® MENTHOL AND ZINC OXIDE menthol, zinc oxide ointment PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:72570 -113 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGR Aqra d-dokument sħiħ