Label: CALAMINE- ferric oxide red lotion
- NDC Code(s): 0904-2533-21
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 23, 2024
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INGREDIENTS AND APPEARANCE
CALAMINE
ferric oxide red lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-2533 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED 8 g in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 8 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:0904-2533-21 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/07/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 01/07/2013 Labeler - Major Pharmaceuticals (191427277) Registrant - Consumer Product Partners, LLC (119091520) Establishment Name Address ID/FEI Business Operations Consumer Product Partners, LLC 119091520 manufacture(0904-2533) Establishment Name Address ID/FEI Business Operations Consumer Product Partners, LLC 119091514 manufacture(0904-2533)