Label: MENTHOL- maximum strength medicated foot powder talc free 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 May 2, 2023

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  • Active ingredient

    Menthol 1.0%

  • Purpose

    External analgesic

  • Use

    for the temporary relief of pain and itching associated with minor skin irritations

  • Warnings

    For external use only.

    When using this product

    • avoid contact with eyes

    Stop and consult a doctor if

    • conditions worsens
    • symptoms persists for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years of age and older, apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age, consult a doctor
    • wash and dry feet thoroughly
    • sprinkle powder liberally on feet, between toes and on bottoms of feet
  • Inactive ingredients

    benzathonium Chloride, eucalyptus oil, peppermint oil, sodium bicarbonate, tricalcium phosphate, zea mays (corn) starch

  • Questions?

    Call 1-866-964-0939

  • Principal Display Panel

    Caring Mill

    maximum strength

    medicated

    foot powder

    external analgesic/menthol 1 %

    talc- free

    triple action formula

    • absorbs moisture
    • relieve itching
    • helps control foot odor

    NET WT 10 OZ (283 g)

    image 1

  • INGREDIENTS AND APPEARANCE
    MENTHOL 
    maximum strength medicated foot powder talc free powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81522-075
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.8 g  in 283 g
    Inactive Ingredients
    Ingredient NameStrength
    ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81522-075-01283 g in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package05/02/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/02/2023
    Labeler - FSA Store Inc. (049283340)
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