Label: SHEFFIELD ZINC OXIDE- zinc oxide ointment

  • NDC Code(s): 11527-065-34
  • 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 20%

  • Purpose

    Skin Protectant

  • Uses

    • helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.
    • dries the oozing and weeping of poison ivy, poison oak and poison sumac.
  • Warnings

    For external use only

    When using this product, avoid contact with the eyes

    Stop use and ask a doctor if condition worsens or does not improve within 7 days

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

  • Directions

    • apply liberally as often as necessary

    For diaper rash:

    • change wet or soiled diapers promptly
    • cleanse the diaper area and allow to dry
    • apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • Inactive ingredients

    mineral oil, petrolatum

  • Questions or comments?

    Call 1-800-222-1087

    Store at room temperature 20° - 25°C (68° - 77°F).

  • PRINCIPAL DISPLAY PANEL

    Sheffield Pharmaceuticals -Tube label 


    SKIN PROTECTANT

    Zinc Oxide
    Ointment USP
    • provides soothing relief from poison ivy,
    oak and sumac
    • Treats and prevents diaper rash

    NET WT 1 OZ (28g)

    Sheffield Zinc Oxide 1 oz tube

    Sheffield Zinc Oxide 1 oz tube

  • PRINCIPAL DISPLAY PANEL

    Sheffield Pharmaceuticals Zinc Oxide Ointment USP- Carton label 

    Skin protectant 

    Help Soothe & Protect Chafed Skin

    NET WT 1 oz (28g)

    5434572-Sheffield Pharma 1 oz Zinc Oxide Carton

    5434572-Sheffield Pharma 1 oz Zinc Oxide Carton

  • INGREDIENTS AND APPEARANCE
    SHEFFIELD ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-065
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11527-065-341 in 1 CARTON01/11/2005
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/11/2005
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
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