Label: DIAPER RASH CREAM 2.5OZ- zinc oxide cream

  • NDC Code(s): 58503-170-01
  • Packager: China Ningbo Shangge Cosmetics Technology Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2023

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  • Active ingredient

    Zinc Oxide 40%

  • Purpose

    Skin protectant

  • Use

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps seal out wetness
  • Warnings

    For external use only

    Stop use and ask a doctor if

    Stop use and ask a doctor if

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

    When using this product

    When using this product do not get into eyes.

    Keep out of reach of children

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

  • Directions

    • change wet and soilded diapers promtly
    • cleanse the diaper area
    • allow to dry
    • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers will be prolonged.
  • Other information

    • store at 68º-77ºF(20º to 25ºC)
    • do not use if tube seal under cap is broken or missing
  • Inactive ingredients

    Petrolatum

    Mineral Oil

    Lanolin

    Isopropyl Myristate

    Beeswax

    Tocopheryl Acetate

    Cod Liver Oil

    Aloe Barbadensis Leaf Juice

  • PRINCIPAL DISPLAY PANEL

    label 1label 2

  • INGREDIENTS AND APPEARANCE
    DIAPER RASH CREAM 2.5OZ 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-170
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.4 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-170-011 in 1 BOX12/04/2023
    171 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01612/04/2023
    Labeler - China Ningbo Shangge Cosmetics Technology Corp. (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetics Technology Corp.529287434manufacture(58503-170)
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