Label: DR. SHEFFIELD DIAPER RASH- zinc oxide ointment

  • NDC Code(s): 11527-058-40, 11527-058-41
  • Packager: Sheffield Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc Oxide 40%

  • Purpose

    Skin protectant

  • Uses

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

    For external use only

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    • condition worsens
    • 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 ointment 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 room temperature 15° - 30°C (59° - 86°F)

  • Inactive ingredients

    BHA, Cod liver oil, Fragrance, Lanolin, Petrolatum, Talc, Water

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - Carton Label

    NDC 11527-058-41

    Dr. Sheffield's

    Made in the USA

    Diaper Rash
    Ointment

    40% Zinc Oxide Skin Protectant

    • Promotes healing

    • Relieves chafing

    • Paraben free

    Helps Treat and
    Prevent Diaper Rash

    NET WT. 2 oz. (56g)

    Principal Display Panel - Carton Label

    Principal Display Panel - Carton Label

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - Tube Label

    NDC 11527-058-41

    Dr. Sheffield's

    Made in the USA

    Diaper Rash
    Ointment

    NET WT. 2 oz. (56g)

    40% Zinc Oxide Skin Protectant

    Helps Treat and Prevent Diaper Rash

    Principal Display Panel - Tube Label

    Principal Display Panel - Tube Label

  • INGREDIENTS AND APPEARANCE
    DR. SHEFFIELD DIAPER RASH 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-058
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE400 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    TALC (UNII: 7SEV7J4R1U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11527-058-411 in 1 CARTON01/09/2002
    156 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11527-058-401 in 1 CARTON01/17/2014
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/09/2002
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797MANUFACTURE(11527-058)
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