Label: CALAMINE- ferric oxide red lotion
- NDC Code(s): 55316-063-26
- Packager: DZB Brands, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 19, 2024
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- Active ingredient
- Purpose
- Use
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
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- Inactive ingredients
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
CALAMINE
ferric oxide red lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55316-063 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 80 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 80 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENTONITE (UNII: A3N5ZCN45C) CALCIUM HYDROXIDE (UNII: PF5DZW74VN) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55316-063-26 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/05/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 02/05/2008 Labeler - DZB Brands, LLC (090322194) Registrant - Consumer Product Partners, LLC (119091520) Establishment Name Address ID/FEI Business Operations Consumer Product Partners, LLC 119091514 manufacture(55316-063) Establishment Name Address ID/FEI Business Operations Consumer Product Partners, LLC 119091520 manufacture(55316-063)