Label: ZINC OXIDE cream

  • NDC Code(s): 69367-188-04
  • Packager: Westminster Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 29, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc Oxide 22%

  • Purpose

    Skin Protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps protect skin from wetness.
  • Warnings

    For external use only

    When using this product do not get into eyes

    Stop use and ask a doctor if

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • 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 anytime when exposure to wet diapers may be prolonged.
  • Other information

    • store at 20-30°C (68-86 °F)
  • Inactive ingredients

    aloe barbadensis leaf juice, cetyl alcohol, glycerin, glyceryl stearate SE, isopropyl palmitate, mineral oil, PEG-100 stearate, phenoxyethanol, purified water, tocopheryl acetate (vitamin E), stearyl alcohol, white petrolatum

  • Questions?

    Call 1-844-221-7294.

  • PRINCIPAL DISPLAY PANEL - 113 gram Tube Label

    Soothing Aloe &
    Vitamin E

    NDC 69367-188-04

    Zinc Oxide 22%

    Daily Moisturizing
    Diaper Rash Cream

    Premium Skin Protectant

    • Helps Heal, Soothe & Prevent Diaper Rash
    • Protects Chafed Skin
    • Gentle on Sensitive Skin

    NET WT: 4 oz (113 grams)

    Westminster
    Pharmaceuticals

    PRINCIPAL DISPLAY PANEL - 113 gram Tube Label
  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69367-188
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE22 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69367-188-04113 g in 1 TUBE; Type 0: Not a Combination Product07/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM01607/29/2021
    Labeler - Westminster Pharmaceuticals, LLC (079516651)
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