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 21, 2013

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  • Active ingredients

    Active ingredients

    Menthol 0.15%

    Zinc oxide 1.0%

  • Purpose

    Purpose

    External analgesic

    Skin protectant

  • Uses

    Uses for the temporary relief of pain and itching due to:

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

    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

    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, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate

  • Disclaimer

    This product is not manufractured or distributed by Chattem, Inc., owner of the registered tradmark Gold Bond

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

  • Advese reactions

    Distributed by: DZA Brands, LLC

    2110 Excutive Drive

    Salisbury, NC 28147

    For Product questions or concerns

    contact us at 1-866-322-2439. Please include UPC number and code from package

  • Principal Display Panel

    Healthy

    Accents

    medicated

    body powder

    external analgesic

    cooling - absorbing- itch relieving

    Compare to the active ingredients of Gold Bond Medicated Body Powder

    NET WT 10 OZ (283 g)

    image description

  • INGREDIENTS AND APPEARANCE
    MEDICATED 
    menthol, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-551
    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:55316-551-38283 g in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/01/2011
    Labeler - DZB Brands, LLC (090322194)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    M+K Packaging047022405manufacture(55316-551)
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