Label: BODY- menthol, zinc oxide 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 March 18, 2013

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  • Active ingredient

    Active ingredients

    Menthol 0.15%

    Zinc oxide 1.0%

  • Purpose

    Purpose

    External analgesic

    Skin protectant

  • Uses

    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

    dries the oozing and weeping of:

    • poison ivey
    • 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

    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

    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 year 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

  • Questions

    Questions? Call 1-888-593-0593

  • Disclaimer

    Ths product is not manufacgtured or distributed by Chattem, Inc., owener of the registered tradmark of Gold Bond

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

  • Adverse reactins

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD, DEERFIELD, IL 60015

    100% SATISFACTIN GUARANTEED

    walgreens.com

    MADE IN U.S.A. WITH U.S. AND FOREIGN COMPONENTS

  • Principal Display Panel

    Studio 35

    MEDICATED

    BODY POWDER

    SKIN PROTECTANT

    EXTERNAL ANALGESIC

    COOLING, ABSORBING

    + ITCH RELIEVING

    Compare to Gold Bond Medicated Body Powder active ingredient

    NET T 10 OZ (283 g)

    image description

  • INGREDIENTS AND APPEARANCE
    BODY 
    menthol, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0551
    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 CATION - UNII:13S1S8SF37) ZINC CATION10 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:0363-0551-38283 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/31/2003
    Labeler - Walgreen Co. (008965063)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    MK Packaging047022405manufacture(0363-0551)
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