Label: BODY- menthol powder

  • Category: HUMAN OTC DRUG LABEL

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 April 13, 2018

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  • Active ingredient

    Menthol 0.15%

  • Purpose

    External analgesic

  • Uses

    for temporary relief of pan and itching due to:

    • mnor cuts
    • sunburn
    • insect bites
    • poison ivy
    • poison oak
    • poison sumac
    • scrapes 
    • minor burns
    • minor skin irritations
  • warnings

    For external use only

  • When using this product

    avoid contact with the eyes

  • Stop use and ask a doctor

    If condition worsens, or if symtpoms persist 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 - do not use, consult a doctor

    • for best results dry skin thoroughly before applying
  • Inactive ingredients

    Zea mays (corn) starch, sodium bicarbonate, tricalcium phosphate, zinc oxide, acacia seyal gum, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate

  • Questions

    Call 1-800-616-2471

  • disclaimers

    This product is not manufactured or distributed by Chattem, distributor of Gold Bond Medicated Body Powder.

    This product is sold by weight, not by volume. Some settling may occur during handling and shipping

  • Adverse Reaction

    Distributed By 

    MAJOR PHARMACEUTICALS

    31778 ENTERPRISE DRIVE

    LIVONIA, MI 48150  USA

  • Principal Display Panel

    NDC 0904-6348-77

    MAJOR

    MEDICATED

    BODY POWDER

    Pain Relieving Powder

    WITH ESSENTIAL OILS

    Compare to Gold Bond Medicated

    Body Powder

    Soothes

    Absorbs Moisture

    Menthol 0.15 % Anti-Itch

    NET WT 10 OZ (283 g)

    image description

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  • INGREDIENTS AND APPEARANCE
    BODY 
    menthol powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6348
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    GUM TALHA (UNII: H18F76G097)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    THYMOL (UNII: 3J50XA376E)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6348-77283 g in 1 BOTTLE; Type 0: Not a Combination Product07/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/01/2013
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    MK Packaging047022405manufacture(0904-6348)
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