Label: ENDIT ZINC OXIDE SKIN PROTECTANT- zinc oxide ointment

  • NDC Code(s): 64068-402-01
  • Packager: Endit Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 15, 2023

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  • Active Ingredient:

    Zinc Oxide 20.00%

  • Purpose:

    Skin Protectant

  • Uses:

    Helps treat and prevent rash associated with diaper use, incontinence, or exposure to feces and urine. Protects chafed skin due to diaper rash and helps seal out wetness.

  • Warnings:

    For external use only.

    do not get in eyes. When using this product

    Stop use and ask 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

    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 (perineum, buttocks, lower abdomen, and inner thighs), and allow to dry.
    • Apply liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to soiled dapers (feces, and/or urine) may be prolonged.
  • Other Ingredients:

    Boric Acid, Calamine, Cornstarch, Juniper Tar, Lanolin, Resorcinol, White Petrolatum

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ENDIT ZINC OXIDE SKIN PROTECTANT 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64068-402
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    JUNIPER TAR (UNII: 1Q84T0P2G3)  
    LANOLIN (UNII: 7EV65EAW6H)  
    RESORCINOL (UNII: YUL4LO94HK)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64068-402-01454 g in 1 JAR; Type 0: Not a Combination Product05/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01605/31/2017
    Labeler - Endit Laboratories, Inc. (065285207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Filltech USA, LLC926433855manufacture(64068-402)
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