Label: MEDICATED BODY- menthol and zinc oxide powder

  • NDC Code(s): 52000-038-25
  • Packager: Universal Distribution Center LLC
  • 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 December 4, 2017

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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 product avoid contact with the eyes.

  • STOP USE

    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

    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/04/2017
    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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