Label: MEDICATED BODY POWDER- menthol and zinc oxide powder 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/13

If you are a consumer or patient please visit this version.

  • Acitves

    Menthol 0.15%
    Zinc Oxide 1.0%

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  • Inactives

    Talc
    Salicylic Acid
    Methyl Salicylate
    Eucalyptol
    Thymol
    Zinc Stearate

    Acacia

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  • Uses

    Temporarily relieves the pain and itch associated with

    Minor cuts

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

    Temporarily relieves the pain and itch

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  • 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.

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  • 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.

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  • Keep Out of Reach of Childrens

    Keep out of reach of childrens.

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  • Product Label
  • INGREDIENTS AND APPEARANCE
    MEDICATED BODY POWDER 
    menthol and zinc oxide powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59240-001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 0.15 g  in 100 g
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    TALC  
    Salicylic Acid  
    ACACIA  
    EUCALYPTOL  
    METHYL SALICYLATE  
    THYMOL  
    ZINC STEARATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59240-001-01 113 g in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 07/18/2013
    Labeler - MAGVERZ INC (078712269)
    Registrant - MAGVERZ INC (078712269)
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