Label: CALAMINE PHENOLATED TOPICAL SUSPENSION- calamine and zinc oxide and phenol lotion
- NDC Code(s): 82645-921-96
- Packager: Pharma Nobis, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 26, 2023
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INGREDIENTS AND APPEARANCE
CALAMINE PHENOLATED TOPICAL SUSPENSION
calamine and zinc oxide and phenol lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82645-921 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 PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENTONITE (UNII: A3N5ZCN45C) CALCIUM HYDROXIDE (UNII: PF5DZW74VN) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82645-921-96 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/16/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 01/01/2008 Labeler - Pharma Nobis, LLC (118564114) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 manufacture(82645-921) , analysis(82645-921) , pack(82645-921) , label(82645-921)