Label: MEDICATED BODY- menthol and zinc oxide powder

  • NDC Code(s): 52000-038-25, 52000-038-26
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 25, 2024

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  • Active Ingredients

    Menthol         0.15%

    Zinc Oxide     1.0%

  • Purpose

    External analgesic

    Skin protectant

  • Uses

    for the temporary relief of pain and itching associated with:

    • Backache
    • Minor Burns
    • Minor Skin Irritations
    • Minor Cuts
    • Sunburn
    • Insect Bites
    • Ooozing and weeping of poison ivy, poison oak and poison sumac can be dried using Universal Medicated Powder
  • Warnings

    For external use only.

  • WHEN USING

    When using this productavoid contact with the eyes.

  • STOP USE

    Stop use and ask a doctor ifcondition 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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center  (1-800-222-1222) immediately.

  • Directions

    • Adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
    • Children under 2 years of age: consult a doctor
    • For best results, dry area thoroughly before applying
  • Inactive Ingredients

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

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

    Medicated Body Powder

    NET WT. 10 oz (283 g)

    label

  • INGREDIENTS AND APPEARANCE
    MEDICATED BODY 
    menthol and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-038
    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 CATION - UNII:13S1S8SF37) ZINC CATION10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    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:52000-038-25283 g in 1 BOTTLE; Type 0: Not a Combination Product12/04/2017
    2NDC:52000-038-26226 g in 1 BOTTLE; Type 0: Not a Combination Product12/04/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01612/04/2017
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52000-038)
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