Label: MEDICATED FOOT POWDER- menthol powder

  • NDC Code(s): 57337-078-01
  • Packager: Rejoice International Inc.
  • 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 November 18, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients                      Purpose

    Menthol 1.0% ............................... Anti-itch

  • PURPOSE

    Uses

    temporarily relieves the pain and itch associated with minor skin irritation on the foot

    • provides itch relief
    • absorbs excess moisture
    • helps control foot odor and odor-causing bacteria
    • cools and soothes irritated skin
  • 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.

  • INDICATIONS & USAGE

    XtraCare

    Medicated Foot Powder

    3x Action

    Itch Relieving

    Odor Controlling

    Moisture Absorbing

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 2 years and older                     apply freely up to 3 or 4 times daily

    children under 2 years                                           ask a doctor before using

    Thoroughly wash and dry feet, sprinkle powder liberally over feet, between toes, and on bottom of feet. For best results apply to affected areas up to 3 or 4 times daily.  Sprinkle inside shoes for maximum freshness.

  • WARNINGS

    Warnings

    For external use only

    • avoid contact with eyes

    Stop using and ask a doctor if

    • condition worsens
    • symptoms do not get better within 7 days
  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MEDICATED FOOT POWDER 
    menthol powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-078
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 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:57337-078-01283 g in 1 PACKAGE; Type 0: Not a Combination Product06/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/15/2015
    Labeler - Rejoice International Inc. (078741245)
    Registrant - Jell Pharmaceuticals Pvt Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(57337-078)
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