Label: MEDLINE- zinc oxide, petrolatum cream

  • NDC Code(s): 53329-176-14
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 3, 2024

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  • Active ingredients (in each gram)

    • White petrolatum 78% w/w, USP
    • Zinc oxide 20% w/w, USP
  • Purpose

    • Skin protectant
  • Uses

    • temporarily protects minor cuts, scrapes and burns
    • helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin
    • helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness
  • Warnings

    for external use only

    When using this product

    • do not get into eyes

    Stope use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • for skin protection: apply as needed
    • for diaper rash: change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
    • apply cream liberally, as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
  • Other information

    • store at controlled room temperature 68-77°F (20-25°C)
    • use only if packaging is intact
  • Inactive ingredients

    cetostearyl alcohol, light mineral oil, macrogol cetostearyl ether 20

  • Manufacturing information

    Manufactured for:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    www.curad.com

    1-800-633-5463

    Made in India

    REF: CUR009814

    V2 RA23GZP

  • 53329-176-14 Package Label

    53329-176-14_V2 RA23GZP

  • INGREDIENTS AND APPEARANCE
    MEDLINE 
    zinc oxide, petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-176
    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
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM78 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-176-1457 g in 1 TUBE; Type 0: Not a Combination Product04/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01604/01/2023
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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