Label: ZINC OXIDE ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 31, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc Oxide (20%w/w)

  • Purpose

    Skin Protectant

  • Uses

    • helps treat and prevent diaper rash
    • dries the oozing and weeping of:
      • poison ivy
      • poison oak
      • poison sumac
  • Warnings

    For external use only

    When using this product

    • do not get into eyes
    • do not use over large area of the body

    Stop Use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again in a few days
    • if you are allergic to any of these ingredients

    Do not use on

    • deep puncture wounds
    • animal bites
    • serious burns

    Keep out of reach of children.

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

  • Directions for Diaper Rash

    • change wet and soiled diaper promptly
    • cleanse the diaper area and allow to dry
    • apply as needed
  • Other information

    • store at 59°-86°F (15°-30°C)
    • avoid excessive heat
  • Inactive Ingredients

    Cetostearyl Alcohol, Cetomacrogol 1000, Lanolin, Light Liquid Paraffin, White Soft Paraffin

  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Box

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69771-109
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 (UNII: I835H2IHHX)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69771-109-381 in 1 BOX01/15/2017
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69771-109-391 in 1 BOX01/15/2017
    256.8 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/15/2017
    Labeler - Geri-Gentle Corporation (080367686)
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