Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
Calamine 8%, Zinc Oxide 8%
Great Lakes Wholesale, Marketing and Sales Inc
TOPICAL
OTC DRUG
Skin Protectant Skin Protectant Dries the oozing and weeping of poison ivy, poison oak, and poison sumac and other skin irritations.
OTC monograph final
HEALTH CARE CALAMINE- CALAMINE 8% AND ZINC OXIDE 8% LOTION GREAT LAKES WHOLESALE, MARKETING AND SALES INC ---------- HEALTH CARE CALAMINE LOTION Drug Facts ACTIVE INGREDIENTS Calamine 8% Zinc Oxide 8% PURPOSE Skin Protectant Skin Protectant USES Dries the oozing and weeping of poison ivy, poison oak, and poison sumac and other skin irritations. WARNINGS For external use only. Use only as directed. Avoid contat with eyes and moucous membranes. ASK A DOCTOR before using on children under 6 years of age. Stop use and ask a doctor if Condition worsens Symptoms last for more than 7 days or clear up and occur again within a few days. KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. DIRECTIONS Adults and children 6 mo. of age and older: Shake well before using. Cleanse the skin with soap and water. Let dry before each use. Apply lotion to the affected area using with soap and water. Let dry before each use. Apply lotion to the affected area using cotton or soft cloth, as often as needed for comfort. Children under 6 mo. of age: Consult a doctor before use. OTHER INFORMATION Store at room temperature 15-30C (59-86F) INACTIVE INGREDIENTS Bentonite Magma, Calcium Hydroxide, Glycerin, and Purified Water. QUESTIONS OR COMMENTS? LABEL NEW LABEL HEALTH CARE CALAMINE calamine 8% and zinc oxide 8% lotion PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:64092-413 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 160 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH BENTONITE (UNII: A3N5ZCN45C) CALCIUM HYDRIDE (UNII: WY779SQ0XW) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:64092- 413-96 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/27/2017 MARKETING INFORMATION Great La Läs hela dokumentet