Label: TALC-FREE MEDICATED BODY- menthol powder
- NDC Code(s): 42669-209-01
- Packager: Davion, Inc
- 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 January 30, 2018
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- Active Ingredient
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- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TALC-FREE MEDICATED BODY
menthol powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42669-209 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 Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) ZINC OXIDE (UNII: SOI2LOH54Z) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SALICYLIC ACID (UNII: O414PZ4LPZ) EUCALYPTUS OIL (UNII: 2R04ONI662) ZINC STEARATE (UNII: H92E6QA4FV) PEPPERMINT OIL (UNII: AV092KU4JH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42669-209-01 283 g in 1 BOTTLE; Type 0: Not a Combination Product 01/30/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/30/2018 Labeler - Davion, Inc (174542928) Registrant - Davion, Inc (174542928) Establishment Name Address ID/FEI Business Operations Davion, Inc 174542928 manufacture(42669-209)