Label: MEDPURA ZINC OXIDE 20% ointment

  • NDC Code(s): 71399-0245-2, 71399-0245-3, 71399-0245-6
  • Packager: Akron Pharma Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 March 11, 2023

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  • Active Ingredient

    Zinc Oxide 20%

  • Purpose

    Skin Protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps seal out wetness
    • protects and dries the oozing and weeping of poison ivy, poison oak, and poison sumac.
  • Warnings

    For External Use Only

    When using this product

    avoid contact with the eyes

    Stop use and ask a doctor if

    if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    • change wet or soiled diapers promptly
    • cleanse the diaper area and allow to dry
    • apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • Other Information

    • store at room temperature 20˚-25˚C (68˚-77˚F)
    • may stain clothing
  • Inactive Ingredients

    alovera gel, mineral oil, white petrolatum

  • Questions and Comments?

    Call toll-free 1-877-225-6999

  • PRINCIPAL DISPLAY PANEL

    2oz

    3oz

    16oz

  • INGREDIENTS AND APPEARANCE
    MEDPURA ZINC OXIDE 20% 
    medpura zinc oxide 20% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-0245
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-0245-21 in 1 CARTON09/12/2022
    156.7 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:71399-0245-31 in 1 CARTON11/04/2021
    285 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:71399-0245-6454 g in 1 JAR; Type 0: Not a Combination Product11/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/04/2021
    Labeler - Akron Pharma Inc. (067878881)
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