Label: OLP DIAPER RASH CREAM A AND D- zinc oxide cream

  • NDC Code(s): 80489-444-01, 80489-444-02, 80489-444-03
  • Packager: OL PHARMA TECH, LLC Drs PHARMACY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 8, 2023

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  • Active Ingredients

    Zinc Oxide 10%

  • Stop using this product and ask a doctor

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

    • helps treat and prevent diaper rash
    • protects minor skin irritation due to diaper rash and helps seal out wetness
  • Warning

    • For external use only
    • when using this product, do not get it into the eye
  • questions

    www.drspharmacyusa.com

  • KEEP OUT OF REACH OF CHILDREN


    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
  • STORAGE AND HANDLING

    store between 20°C to 25 °C ( 68° to 77°F)

  • Inactive Ingredients

    cod liver oil ( contains vitamin A & Vitamin D), propylene glycol, vitamin E, methylparaben, propylparaben, stearic acid, trolamine, ceteareth 20, cetostearyl alcohol, EDTA, mineral oil

  • purpose

    diaper rash cream

  • PRINCIPAL DISPLAY PANEL

    diaper rash

  • INGREDIENTS AND APPEARANCE
    OLP DIAPER RASH CREAM A AND D 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80489-444
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80489-444-011 in 1 CARTON02/01/2022
    120 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:80489-444-021 in 1 CARTON02/01/2022
    245 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:80489-444-031 in 1 CARTON02/01/2022
    349.6 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01602/01/2022
    Labeler - OL PHARMA TECH, LLC Drs PHARMACY (021170377)
    Registrant - OL PHARMA TECH, LLC Drs PHARMACY (021170377)
    Establishment
    NameAddressID/FEIBusiness Operations
    OL PHARMA TECH, LLC Drs PHARMACY021170377manufacture(80489-444)
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