Label: MEDICATED BODY POWDER- menthol powder

  • NDC Code(s): 30400-506-01
  • Packager: Jell Pharmaceuticals Pvt Ltd
  • 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 October 5, 2021

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  • Drug Facts Active Ingredients

    Menthol 0.15 %

  • Purpose

    External Analgesic

  • Uses

    for the temporary relief of the pain and itch associated with

    • minor cuts
    • scrapes
    • sunburn
    • insect bites
    • prickly heat
    • rashes
    • minor burns
    • minor skin irritations
    • dries the oozing of poison ivy, oak and sumac.

  • Warnings

    For external use only

  • When usin this product

    Avoid contact with eyes. Not for genital area.

  • Stop use and ask a doctor if

    • condition worsens
    • Redness, irritation, swelling or pain persist or increases
    • symptoms do not get better within 7 days or clear up and occur again within a few days
  • Keep out of reach of children

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • adults and children 2 years of age and over, apply freely up to 3 or 4 times daily
    • Children under 2 years: consult a physician
    • for best results, dry skin thoroughly before use
  • Inactive Ingredients

    acacia seyl gum, eucalyptol, methyl salicylate, salicylic acid, sodium bicarbonate, thymol, tricalciun phosphate, zea mays (corn stach), zinc oxide, zinc stearate

  • Equate Medicated Body Powder Original

    Label

  • INGREDIENTS AND APPEARANCE
    MEDICATED BODY  POWDER
    menthol powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30400-506
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 g  in 283 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    ACACIA (UNII: 5C5403N26O)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    THYMOL (UNII: 3J50XA376E)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    ZEA MAYS WHOLE (UNII: 1G5HNE09V8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30400-506-01283 g in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2020
    Labeler - Jell Pharmaceuticals Pvt Ltd (726025211)
    Registrant - Jell Pharmaceuticals pvt ltd (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt Ltd.726025211manufacture(30400-506)
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