Label: CALAMINE- ferric oxide red lotion
- NDC Code(s): 36800-063-26, 36800-063-30, 36800-063-34
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 8, 2022
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- Active ingredents
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INGREDIENTS AND APPEARANCE
CALAMINE
ferric oxide red lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-063 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-063-30 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/15/1991 2 NDC:36800-063-26 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/15/1991 05/28/2021 3 NDC:36800-063-34 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/15/1991 05/28/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 09/15/1991 Labeler - Topco Associates LLC (006935977) Registrant - Vi Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 790752542 manufacture(36800-063) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 088520668 manufacture(36800-063)
