Label: MEDICATED- menthol, zinc oxide 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 18, 2013

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  • Active ingredients

    Active ingredients

    Menthol 0.15%

    Zinc Oxide 1.0%

  • Purpose

    Purpose

    Exteranal analgesic

    Skin protectant

  • Use

    Uses for temporary relief of pain and itching due to:

    • minor cuts
    • sunburn
    • insects bites
    • poison ivy
    • poison oak
    • poison sumac
    • scrapes
    • minor burns
    • minor skin iritations

    dries the oozing and weeping of

    • poison ivy
    • poison oak
    • poison sumac
  • Warnings

    Warnings

    For external use only

  • When using this product

    When using this product avoid contact with the eyes

  • Stop use and ask a doctor if

    Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    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

    Inactive ingredients talc, acacia, eucaluptol, methyl salicylate, salicylic acid, thymol, zinc stearate

  • Disclaimer

    This product is not manufactured or distributed by Chattem, Inc., owner of the regstered trademark Gold Bond.

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

  • Adverse Reaction

    SATISFACTION GUARANTEED OR YOUR MONEY BACK

    Manufactured For Your Military Exchanges

    By: Vi-Jon

    8515 Page Avenue

    St. Louis, MO 63114

  • Principal display panel

    Exchange

    Select

    MEDICATED

    BODY POWDER

    ABSORBS MOISTURE

    Compare to the Active Ingredients

    of Gold Bond medicated Body Powder

    Skin Protectant

    External Analgesic

    NET WT 10 OZ (283 g)

    image description

  • SPL UNCLASSIFIED SECTION

  • SPL UNCLASSIFIED SECTION

  • INGREDIENTS AND APPEARANCE
    MEDICATED 
    menthol, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-551
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.5 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    ACACIA (UNII: 5C5403N26O)  
    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:55301-551-38283 g in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/10/2003
    Labeler - Your Military Exchange (001695568)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    M K Packaging047022405manufacture(55301-551)
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