Label: TALC-FREE MEDICATED BODY- menthol 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 January 30, 2018

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  • Active Ingredient

    Menthol 0.15%

  • Purpose

    External Analgesic

  • Uses

    Temporary relief of pain and itch associated with:

    • minor cuts
    • sunburn
    • insect bites
    • scrapes
    • minor burns
    • minor skin irritations
  • Warning

    • For external use only
    • Avoid contact with eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within few days

    Keep out of reach of children

    In case of accidental ingestion, get medical help or contact a poison control center right away.

  • Directions

    Remove seal beneath cap before first use. Do not use if seal is broken or missing.

    • adults and children 2 years and older - apply freely upto 3 or 4 times daily
    • children under 2 years - ask a doctor

    For best results, dry skin throughly before applying

  • Inactive ingredients

    Zea Mays (Corn) Starch, zinc oxide, Tricalcium Phosphate, Sodium Bicarbonate, salicylic acid, zinc stearate, Eucalyptus oil, Peppermint Oil

  • PRINCIPAL DISPLAY PANEL

    NDC 42669-209-01

    Compare to active ingredient in Gold Bond® Medicated Body Powder*

    talc-free medicated body powder

    triple relief formulahelps absorb moisture

    helps soothe skin and relieves itching

    NET WT 10oz (283 g)

    Label

  • INGREDIENTS AND APPEARANCE
    TALC-FREE MEDICATED BODY 
    menthol powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42669-209
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42669-209-01283 g in 1 BOTTLE; Type 0: Not a Combination Product01/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/30/2018
    Labeler - Davion, Inc (174542928)
    Registrant - Davion, Inc (174542928)
    Establishment
    NameAddressID/FEIBusiness Operations
    Davion, Inc174542928manufacture(42669-209)
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