Label: PERSONAL CARE- medicated foot 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 1 percent               External analgesic
  • PURPOSE

    Uses     for the temporary relief of the pain and itch associated with minor skin

    irritation on the foot - absorbs excess moisture - helps control foot odor and

    odor-causing bacteria - cools and soothes irritated skin
  • 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
  • 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
    - wash and dry feet, sprinkle powder liberally over feet, between toes, on bottoms of feet, and in shoes

  • INACTIVE INGREDIENT

    Inactive ingredients
    talc, sodium bicarbonate, acacia, benzethonium chloride, eucalyptus oil, peppermint oil

  • PRINCIPAL DISPLAY PANEL

    Personal Care Medicated Foot Powder

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE 
    medicated foot powder powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9091
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol20 mg  in 2 g
    Inactive Ingredients
    Ingredient NameStrength
    Talc (UNII: 7SEV7J4R1U)  
    Sodium Bicarbonate (UNII: 8MDF5V39QO)  
    Acacia (UNII: 5C5403N26O)  
    Benzethonium chloride (UNII: PH41D05744)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-9091-1283 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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