Label: LEADER ZINC OXIDE- zinc oxide ointment

  • NDC Code(s): 70000-0334-1
  • Packager: Cardinal Health 110,Inc.
  • 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 January 6, 2022

If you are a consumer or patient please visit this version.

  • 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
    • symptoms last more than 7 days to 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

    • 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

    For Poison Ivy, poison oak and poison sumac;

    • cleanse the affect area and pat dry 
    • apply ointment liberally, as often as necessary, using a cotton ball, sterile swab or gauze
    • wash hands after use.
  • 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 – Jar Label

    Leader®       NDC 70000-0334-1

    Zinc Oxide

    Ointment USP•

    Multi Purpose Skin Protectant 

    provides soothing relief from poison ivy,

    oak and sumac

    Treats and prevents diaper rash

    Net Wt 1 lb (454 g)

    Principal Display Panel – Jar Label

  • INGREDIENTS AND APPEARANCE
    LEADER ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0334
    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:70000-0334-1454 g in 1 JAR; Type 0: Not a Combination Product03/29/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/29/2019
    Labeler - Cardinal Health 110,Inc. (063997360)