Label: ENDIT ZINC OXIDE SKIN PROTECTANT- zinc oxide ointment

  • NDC Code(s): 64068-402-01
  • Packager: Endit Laboratories, 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 29, 2021

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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.

    When using this product do not get in eyes.

    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 finalpart34705/31/2017
    Labeler - Endit Laboratories, Inc. (065285207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kalchem International Inc.805294014manufacture(64068-402) , label(64068-402) , pack(64068-402)