দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
Calamine 8% Zinc oxide 8%
Perrigo Direct, Inc.
TOPICAL
OTC DRUG
Skin Protectant dries the oozing and weeping of poison:•ivy • oak • sumac - condition worsens - symptoms last more than 7 days or clear up and occur again within a few days
OTC monograph final
CALAMINE - FERRIC OXIDE RED LOTION PERRIGO DIRECT, INC. _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._ ---------- CALAMINE LOTION 063.001'063AA ACTIVE INGREDIENTS Calamine 8% Zinc oxide 8% PURPOSE Skin Protectant USE dries the oozing and weeping of poison:•ivy • oak • sumac WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT Do not get into eyes STOP USE AND ASK A DOCTOR IF condition worsens symptoms last more than 7 days or clear up and occur again within a few days KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away DIRECTIONS • shake well before using • apply as needed OTHER INFORMATION store at 59⁰ - 86⁰ F INACTIVE INGREDIENTS bentonite magma, calcium hydroxide, glycerin, purified water Distributed by: Perrigo Direct, Inc Peachtree City, GA 30269 www.PerrigoDirect.com 1-866-593-0593 GoodSense is a registered trademark of L. Perrigo Company. PRINCIPAL DISPLAY PANEL GOODSENSE NDC 75981-063-30 Calamine Lotion Calamine Topical Suspension USP Skin Protectant Poison Ivy, Oak, Sumac, Drying Lotion 6 FL OZ (177 mL) CALAMINE ferric oxide red lotion PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:50804-063 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED 8 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 8 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH BENTONITE (UNII: A3N5ZCN45C) CALCIUM HYDROXIDE (UNII: PF5DZW74VN) GLYCERIN (UNII: PDC6A3C0OX) Perrigo Direct, Inc. WATER (UNII: 059QF0KO0R) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:50804- 063-30 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/15/1992 MARKETING INFO সম্পূর্ণ নথি পড়ুন