Label: BODY- menthol, zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 11822-0551-3 - Packager: Rite Aid
- 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 21, 2013
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- Active ingredient
- Purpose
- Use
- Warnings
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
- Directions
- Inactive ingredients
- Disclaimer
- advese reactions
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- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
BODY
menthol, zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0551 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:11822-0551-3 283 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 09/05/2003 Labeler - Rite Aid (014578892) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations M+K Packaging 047022405 manufacture(11822-0551)