Label: MEDICATED- menthol, zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 55301-551-38 - Packager: Your Military Exchange
- 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 18, 2013
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- Active ingredients
- Purpose
- Use
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Inactive ingredients
- Disclaimer
- Adverse Reaction
- Principal display panel
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
MEDICATED
menthol, zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-551 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 OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength TALC (UNII: 7SEV7J4R1U) ACACIA (UNII: 5C5403N26O) 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:55301-551-38 283 g in 1 BOTTLE, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/10/2003 Labeler - Your Military Exchange (001695568) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations M K Packaging 047022405 manufacture(55301-551)