Label: PERSONAL CARE - menthol and zinc oxide powder

  • NDC Code(s): 29500-9090-1
  • Packager: Personal Care Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 09/09

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

  • ACTIVE INGREDIENT

    Active ingredients                                      Purpose
    Menthol 0.15 percent                   External analgesic
    Zinc Oxide 1.0 percent                     Skin protectant
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  • PURPOSE

    Uses     for the temporary relief of the pain and itch associated with:
    - minor cuts - scrapes - sunburn - insect bites - prickly heat - rashes
    - minor burns - minor skin irritation - dries the oozing of poison ivy, oak
    and sumac. Close
  • WARNINGS

    Warnings
    For external use only
    When using this product avoid contact with eyes. Close
  • ASK DOCTOR

    Stop using and ask a doctor if
    - condition worsens 
    - symptoms do not get better within 7 days or clear up and occur again within a few days
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, get medical help or
    contact a Poison Control Center right away. Close
  • DOSAGE & ADMINISTRATION

    Directions
    adults and children 2 years and older, apply freely up to 3 or 4 times daily
    - under 2 years: ask a doctor before using
    - for best results, dry skin thoroughly before use.
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  • INACTIVE INGREDIENT

    Inactive ingredients
    talc, acacia, eucalyptus oil, methyl salicylate, salicylic acid, thymol, zinc stearate

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  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE 
    medicated body powder powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:29500-9090
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (Menthol) Menthol 3 mg  in 2 g
    Zinc Oxide (Zinc Cation) Zinc Oxide 20 mg  in 2 g
    Inactive Ingredients
    Ingredient Name Strength
    Talc  
    Acacia  
    Eucalyptol  
    Methyl Salicylate  
    Salicylic Acid  
    Thymol  
    Zinc Stearate  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:29500-9090-1 283 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 09/01/2009
    Labeler - Personal Care Products, Inc. (603124298)
    Establishment
    Name Address ID/FEI Business Operations
    Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture
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