Label: GOLD BOND MEDICATED ORIGINAL STRENGTH BODY- menthol 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 March 17, 2023

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  • SPL UNCLASSIFIED SECTION

    Gold Bond Medicated

    Original Strength Body Powder

    Drug Facts

  • Active ingredient

    Menthol 0.15%

    Purpose

    Anti-itch

  • Uses

    temporarily relieves the pain and itch associated with:

    ■ minor cuts ■ sunburn ■ insect bites ■ scrapes ■ minor burns ■ minor skin irritations

  • Warnings

    For external use only

    When using this product

    ■ avoid contact with eyes

    Stop use and ask a doctor if

    ■ condition worsens

    ■ symptoms persist for more than 7 days or clear up and occur again within a few days

    ■ redness, irritation, swelling or pain persists or increases

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    ■  adults and children 2 years and older: apply freely up to 3 or 4 times daily  

    ■  children under 2 years: ask a doctor

    ■ for best results dry skin thoroughly before applying

  • Inactive ingredients

    zea mays (corn) starch, zinc oxide, acacia senegal gum, silica, tricalcium phosphate, eucalyptol, methyl salicylate, salicylic acid, zinc stearate, thymol

  • PRINCIPAL DISPLAY PANEL

    Gold Bond

  • INGREDIENTS AND APPEARANCE
    GOLD BOND MEDICATED ORIGINAL STRENGTH BODY 
    menthol powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-225(NDC:41167-0110)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    ACACIA (UNII: 5C5403N26O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    THYMOL (UNII: 3J50XA376E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67751-225-011 in 1 BLISTER PACK03/01/2021
    128 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2021
    Labeler - Navajo Manufacturing Company Inc. (091917799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Navajo Manufacturing Company Inc.136941411relabel(67751-225) , repack(67751-225)
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