Label: MEDICATED BODY- menthol and 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 November 3, 2015

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  • ACTIVE INGREDIENT

    Active Ingredients

    Menthol        0.15%

    Zinc Oxide      1.0%

  • PURPOSE

    Purpose

    Anti-itch

  • INDICATIONS & USAGE

    Uses

    For the temporary relief from pain and itching associated with minor cuts and burns, sunburn, scrapes, insect bites, and other minor skin irritation. Also for drying up poison oak, which helps control the growth of fungi associated with athlete's foot and jock itch.

  • WARNINGS

    Warning

    For external use only.

  • WHEN USING

    Avoid contact with eyes.

  • ASK DOCTOR

    If symptoms persist more than 7 days, worsen with use or return within a few days of cleaning up, discontinue use of this product and consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    Use after shower, bath or exercise. Use in footwear and on feet. Dry skin completely before applying. For adults and children over 2 years; apply to affected area not more than 3 or 4 times daily. Children Under 2 Years; Consult a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    talc, acacia, eucalyptus oil, methyl salicylate, salicylic acid, thymol, zinc stearate.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    MEDICATED BODY POWDER

    NET WT. 10 OZ. (283g)

    product label

  • INGREDIENTS AND APPEARANCE
    MEDICATED BODY 
    menthol and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-024
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.15 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    ACACIA (UNII: 5C5403N26O)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    THYMOL (UNII: 3J50XA376E)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-024-25283 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/03/2015
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52000-024)
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