Label: BODY- menthol powder

  • NDC Code(s): 41250-043-38
  • Packager: Meijer Distribution, Inc
  • 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 April 25, 2022

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  • Active ingredient

    Menthol 0.15%

  • Purpose

    External analgesic

  • Uses

    for temporary relief of pan and itching due to:

    • minor burns
    • sunburn
    • minor cuts
    • scrapes
    • insect bites
    • minor skin irritations
    • rashes due to 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 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

    Zea mays (corn) starch. sodium bicarbonate, tricalcium phosphate, zinc oxide, acacia seyal gum, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate

  • disclaimers

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

  • Adverse reactions

    DISTRIBUTED BY

    MEIJER DISTRIBUTION, INC

    GRAND RAPIDS, MI 49544

    www.meijer.com

  • principal display panel

    Meijer

    MEDICATED

    BODY POWDER

    External Analgesic

    TRIPLE BENEFITS

    • Itch Relief
    • Cooling
    • Absorbent

    Pain Relieving Powder

    Menthol 0.15%

    This product does not contain talc

    NET WT 10 OZ (283 g)

    image description

  • INGREDIENTS AND APPEARANCE
    BODY 
    menthol powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-043
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    GUM TALHA (UNII: H18F76G097)  
    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:41250-043-38283 g in 1 BOTTLE; Type 0: Not a Combination Product11/15/1987
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/15/1987
    Labeler - Meijer Distribution, Inc (006959555)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    MK Packaging790752542manufacture(41250-043)
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