TALC-FREE MEDICATED BODY (MENTHOL) POWDER [DAVION, INC]

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TALC-FREE MEDICATED BODY (MENTHOL) POWDER [DAVION, INC]
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NDC 42669-209-01
Set ID 27b9b4dc-4d4f-4e9d-b388-a7c6807a0e9b
Category HUMAN OTC DRUG LABEL
Packager Davion, Inc
Generic Name
Product Class
Product Number
Application Number PART348
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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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