Label: TOPCARE CALAMINE- calamine 8% and zinc oxide 8% lotion lotion
- NDC Code(s): 36800-702-96
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 2023
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- ACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
TOPCARE CALAMINE
calamine 8% and zinc oxide 8% lotion lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-702 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) CARRAGEENAN (UNII: 5C69YCD2YJ) XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) CALCIUM HYDROXIDE (UNII: PF5DZW74VN) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-702-96 177 mL in 1 CONTAINER; Type 0: Not a Combination Product 07/16/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 07/16/2019 Labeler - TOPCO ASSOCIATES LLC (006935977) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 analysis(36800-702) , manufacture(36800-702) , label(36800-702) , pack(36800-702)