Label: MEDICATED BODY- 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 May 21, 2012

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  • ACTIVE INGREDIENT

    Active ingredients
    Menthol 0.15%
    Zinc oxide 1.0%

    Purpose
    External analgesic
    Skin protectant
  • INDICATIONS & USAGE

    Uses for 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 avoid contact with the eyes

    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.  If swallowed, get medical help or contact a Poison Control Center right away
  • DOSAGE & ADMINISTRATION

    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 INGREDIENT

    Inactive ingredients talc, acacia, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate,
  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by Chattem, Inc., distributor of Gold Bond Medicated Body Powder.
    This product is sold by weight, not volume.  Some settling may occur during handling and shippint
  • ADVERSE REACTIONS

    Another Quality Product
    Distributed By McKesson
    One Post Street
    San Francisco, CA 94104
    Money Back Guarantee
    Please visit us at
    www.sunmarkbrand.com
  • PRINCIPAL DISPLAY PANEL

    Sunmark
    Compare to
    Gold Bond
    Medicated
    Body
    Powder
    Skin Protectant
    External Analgesic
    Cooling
    Absorbing
    Itch Relieving
    NET WT 10 OZ (283 g)
    image of principal display panel
  • INGREDIENTS AND APPEARANCE
    MEDICATED BODY 
    menthol, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-834
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.15 g  in 100 kg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.0 g  in 100 kg
    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:49348-834-92.283 kg in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/18/1994
    Labeler - McKesson (177667227)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    M+K Packaging047022405manufacture
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