Label: BODY- menthol powder
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Contains inactivated NDC Code(s)
NDC Code(s): 0904-6348-77 - Packager: Major Pharmaceuticals
- 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 April 13, 2018
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- Active ingredient
- Purpose
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- When using this product
- Stop use and ask a doctor
- keep out of reach of children
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- Inactive ingredients
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INGREDIENTS AND APPEARANCE
BODY
menthol powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6348 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 Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) SODIUM BICARBONATE (UNII: 8MDF5V39QO) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) ZINC OXIDE (UNII: SOI2LOH54Z) 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:0904-6348-77 283 g in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/01/2013 Labeler - Major Pharmaceuticals (191427277) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations MK Packaging 047022405 manufacture(0904-6348)