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 May 29, 2013

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  • Active Ingredients

    Menthol 0.15%

    Zinc oxide 1.0%

  • Purpose

    External analgesic

    Skin protectant

  • Uses

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

    • monor 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

    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

  • 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

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

  • disclaimer

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

    Made in the USA with US and foreign components

  • Adverse Reactions

    Vi-Jon

    One Swan Drive

    Smyrna, TN 37167

  • Principal Display Panel

    NDC 0869-0551-38

    SWAN

    medicated

    Body Powder

    skin protectant/topical analgesic

    triple action

    • Cooling
    • Absorbing
    • Itch Relieving

    Compare to 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:0869-0551
    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 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:0869-0551-38283 g in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/12/2003
    Labeler - Vi-Jon (790752542)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    M+K Packaging047022405manufacture(0869-0551)
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