Label: MEDICATED BODY POWDER- menthol and zinc oxide powder

  • Category: HUMAN OTC DRUG LABEL

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 July 15, 2013

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  • Acitves

    Menthol 0.15%
    Zinc Oxide 1.0%

  • Inactives

    Talc
    Salicylic Acid
    Methyl Salicylate
    Eucalyptol
    Thymol
    Zinc Stearate

    Acacia

  • Uses

    Temporarily relieves the pain and itch associated with

    Minor cuts

    • Sunburn Insect Bites
    • Scrapes Prickly
    • HeatMinor
    • Burns Rashes
    • Minor Skin Irritations
  • Purpose

    Temporarily relieves the pain and itch

  • Directions

    • Adults and children 2 years and older apply freely up to 3 or 4 times daily.
    • Children under 2 years ask a doctor.
    • For best results dry skin thoroughly before applying.

  • Warning

    For external use only.

    When using this product avoid contact with eyes.

    Stop use and ask doctor if condition worsens, symptomos do not get better within 7 days.

  • Keep Out of Reach of Childrens

    Keep out of reach of childrens.

  • Product Label

    image Product Label

  • INGREDIENTS AND APPEARANCE
    MEDICATED BODY POWDER 
    menthol and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59240-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.15 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    Salicylic Acid (UNII: O414PZ4LPZ)  
    ACACIA (UNII: 5C5403N26O)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    THYMOL (UNII: 3J50XA376E)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59240-001-01113 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/18/2013
    Labeler - MAGVERZ INC (078712269)
    Registrant - MAGVERZ INC (078712269)
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