Label: PERSONAL CARE- medicated body powder powder

  • 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 September 7, 2009

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  • ACTIVE INGREDIENT

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

    Warnings
    For external use only
    When using this product avoid contact with eyes.
  • 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
  • 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.
  • 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.
  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    Personal Care Medicated Body Powder

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE 
    medicated body powder powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol3 mg  in 2 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Cation - UNII:13S1S8SF37) Zinc Oxide20 mg  in 2 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-9090-1283 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2009
    Labeler - Personal Care Products, Inc. (603124298)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture
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