Label: MEDICATED BODY- menthol and zinc oxide powder
- NDC Code(s): 52000-038-25, 52000-038-26
- Packager: Universal Distribution Center LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 25, 2024
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- Active Ingredients
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INGREDIENTS AND APPEARANCE
MEDICATED BODY
menthol and zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-038 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.5 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 10 mg in 1 g Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) SODIUM BICARBONATE (UNII: 8MDF5V39QO) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) GUM TALHA (UNII: H18F76G097) EUCALYPTOL (UNII: RV6J6604TK) METHYL SALICYLATE (UNII: LAV5U5022Y) SALICYLIC ACID (UNII: O414PZ4LPZ) THYMOL (UNII: 3J50XA376E) ZINC STEARATE (UNII: H92E6QA4FV) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52000-038-25 283 g in 1 BOTTLE; Type 0: Not a Combination Product 12/04/2017 2 NDC:52000-038-26 226 g in 1 BOTTLE; Type 0: Not a Combination Product 12/04/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 12/04/2017 Labeler - Universal Distribution Center LLC (019180459) Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211) Establishment Name Address ID/FEI Business Operations Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(52000-038)