Label: TOPCARE CALAGESIC- calamine and pramoxine hydrochloride lotion lotion
- NDC Code(s): 36800-268-96
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 18, 2023
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- ACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
TOPCARE CALAGESIC
calamine and pramoxine hydrochloride lotion lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-268 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 80 mg in 1 mL PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) CAMPHOR (NATURAL) (UNII: N20HL7Q941) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-268-96 177 mL in 1 CONTAINER; Type 0: Not a Combination Product 07/16/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 07/16/2019 Labeler - TOPCO ASSOCIATES LLC (006935977) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 analysis(36800-268) , pack(36800-268) , label(36800-268) , manufacture(36800-268)