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 January 21, 2013

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  • Active ingredient

    Active ingredient

    Menthol 0.15%

    Zinc Oxide 1.0%

  • Purpose

    Purpose

    External analgesic

    Skin protectant

  • Use

    Uses for temporary relief of pan and itching due to

    • minor cuts
    • sun burn
    • 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 and ask a doctor

    Stop use and ask a doctor if condition worses, 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 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 handling and shipping.

  • advese reactions

    DISTRIBUTED BY: RITE AID

    30 HUNTER LANE, CAMP HILL, PA 17011

  • Principal Display Panel

    Compare to active ingredients of Gold Bond Medicated Body Powder

    RITE

    AID

    RENEWAL

    BODY POWDER

    MEDICATED

    Itch Relieving,

    Cooling, Absorbing

    Skin Protectant

    External Analgesic

    NET WT 10 OZ (283 g)

    image description

  • SPL UNCLASSIFIED SECTION

  • SPL UNCLASSIFIED SECTION

  • INGREDIENTS AND APPEARANCE
    BODY 
    menthol, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0551
    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:11822-0551-3283 g in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/05/2003
    Labeler - Rite Aid (014578892)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    M+K Packaging047022405manufacture(11822-0551)
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