Label: CALADRYL CLEAR- pramoxine hydrochloride and zinc acetate lotion
- NDC Code(s): 0187-5466-06
- Packager: Bausch Health US, LLC
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated January 1, 2020
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- PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label
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INGREDIENTS AND APPEARANCE
CALADRYL CLEAR
pramoxine hydrochloride and zinc acetate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0187-5466 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength Camphor (Synthetic) (UNII: 5TJD82A1ET) Citric Acid Monohydrate (UNII: 2968PHW8QP) Diazolidinyl Urea (UNII: H5RIZ3MPW4) Glycerin (UNII: PDC6A3C0OX) Methylparaben (UNII: A2I8C7HI9T) Polysorbate 40 (UNII: STI11B5A2X) Propylene Glycol (UNII: 6DC9Q167V3) Propylparaben (UNII: Z8IX2SC1OH) Water (UNII: 059QF0KO0R) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0187-5466-06 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/16/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/16/2013 Labeler - Bausch Health US, LLC (831922468) Establishment Name Address ID/FEI Business Operations Trillium Health Care Products Inc. 255426306 MANUFACTURE(0187-5466)