Label: HEALTH CARE CALAMINE- calamine 8% and zinc oxide 8% lotion
- NDC Code(s): 64092-413-96
- Packager: Great Lakes Wholesale, Marketing and Sales Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 20, 2023
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INGREDIENTS AND APPEARANCE
HEALTH CARE CALAMINE
calamine 8% and zinc oxide 8% lotionProduct 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 Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 01/01/2008 Labeler - Great Lakes Wholesale, Marketing and Sales Inc (361925498) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 manufacture(64092-413) , analysis(64092-413) , pack(64092-413) , label(64092-413)