Label: ENDIT ZINC OXIDE SKIN PROTECTION- zinc oxide ointment

  • NDC Code(s): 64068-500-01, 64068-500-02, 64068-500-03
  • Packager: EndIt Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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  • Drug Facts

  • Active Ingredient

    Zinc Oxide 20%

    Purpose

    Skin Protectant

  • Uses

    • Helps treat and prevent rash associated with diaper use, incontinence, or exposure to feces and urin, 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 a 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.

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

  • Directions

    For treatment of diaper rash:

    • 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 diapers (feces, and/or urine) may be prolonged.
  • Inactive Ingredients

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

  • Package Labeling:56.7 g

    Label

  • Package Labeling:113.4 g

    Label2

  • Package Labeling:227g

    Label3

  • INGREDIENTS AND APPEARANCE
    ENDIT ZINC OXIDE SKIN PROTECTION 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64068-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    JUNIPER TAR (UNII: 1Q84T0P2G3)  
    LANOLIN (UNII: 7EV65EAW6H)  
    RESORCINOL (UNII: YUL4LO94HK)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64068-500-0156.7 g in 1 JAR; Type 0: Not a Combination Product08/09/2022
    2NDC:64068-500-02113.4 g in 1 JAR; Type 0: Not a Combination Product08/09/2022
    3NDC:64068-500-03227 g in 1 JAR; Type 0: Not a Combination Product08/09/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01608/09/2022
    Labeler - EndIt Laboratories, Inc. (065285207)
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