Label: MEDICATED BODY POWDER- menthol powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 15, 2010

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  • ACTIVE INGREDIENT

    Active ingredients
    Menthol 0.15%
    Zinc oxide 1.0%

    Purpose
    External analgesic
    Skin protectant
  • INDICATIONS & USAGE

    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
    • monor 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 form more than 7 days or clear up and occur again withing 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.,
    owner of the registered trademark Gold Bond.

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

    DIST. BY MEIJER DISTRIBUTION, INC.
    2929 WALKER AVE NW
    GRAND RAPIDS, MI 49544
    www.meijer.com
  • PRINCIPAL DISPLAY PANEL

    Meijer
    MEDICATED
    BODY POWDER
    SKIN PROTECTANT
    EXTERNAL ANALGESIC
    COOLING • ABSORBING
    ITCH RELIEVING
    COMPARE TO THE ACTIVE INGREDIENTS OF GOLD BOND
    MEDICATED BODY POWDER
    NET WT 10 OZ (283 g)
    image of principle display panel

  • INGREDIENTS AND APPEARANCE
    MEDICATED BODY POWDER 
    menthol powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-551
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.15 kg  in 100 kg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.0 kg  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:41250-551-38.283 kg in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34805/05/2009
    Labeler - Meijer Distribution, Inc (006959555)
    Registrant - Vi Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon790752542manufacture
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