Label: HEALTH SMART MEDICATED BODY- menthol and zinc oxide powder
- NDC Code(s): 52862-030-01
- Packager: International Wholesale Inc dba Home Smart Products
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 September 2, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- ASK DOCTOR
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- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
HEALTH SMART MEDICATED BODY
menthol and zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52862-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.15 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1 g in 100 g Inactive Ingredients Ingredient Name Strength TRICALCIUM PHOSPHATE (UNII: K4C08XP666) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SALICYLIC ACID (UNII: O414PZ4LPZ) ACACIA (UNII: 5C5403N26O) EUCALYPTUS OIL (UNII: 2R04ONI662) METHYL SALICYLATE (UNII: LAV5U5022Y) THYMOL (UNII: 3J50XA376E) ZINC STEARATE (UNII: H92E6QA4FV) ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52862-030-01 283 g in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/27/2014 Labeler - International Wholesale Inc dba Home Smart Products (161872676) Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211) Establishment Name Address ID/FEI Business Operations Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(52862-030)