Label: HUMCO CALAMINE- calamine 8% and zinc oxide 8% lotion
- NDC Code(s): 0395-0413-96
- Packager: Humco holding Group, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 15, 2023
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INGREDIENTS AND APPEARANCE
HUMCO CALAMINE
calamine 8% and zinc oxide 8% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-0413 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) CALCIUM HYDROXIDE (UNII: PF5DZW74VN) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0395-0413-96 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/13/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 03/25/1998 Labeler - Humco holding Group, Inc. (825672884) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 label(0395-0413) , manufacture(0395-0413) , analysis(0395-0413) , pack(0395-0413)