Label: LEADER BABY SKIN PROTECTANT- baby skin protectant ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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  • Active Ingredient

    Petrolatum 41%

  • Purpose

    Skin Protectant

  • Uses

    • Helps treat and prevent diaper rash
    • Protects chafed skin associated with diaper rash and helps protect from wetness
    • Temporarily protects minor cuts, scrapes,and burns
    • Temporarily protects and helps relieve chapped, or cracked skin and lips
    • Helps protect skin from the drying effects of wind and cold weather
  • Warnings

    For external use only

    When using this product

    do not get in the eyes

    Stop us and ask a doctor if

    • Condition worsens
    • Symptoms last more than 7 days or clear up and occur again within a few days

    Do not use

    • On deep puncture wounds
    • Animal bites
    • Serious burns

    Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Apply as needed or as directed by a physician
    • For diaper rash, change wet and soiled diapers promptly, cleanse the diaper area and allow to dry.
    • Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • Other Information

    • Store at room temperature between 15º-30°C (59°-86°F)
    • Do not use if safety seal is broken or missing
  • Inactive Ingredients

    Ceresin, Dexpanthenol, Glycerin, Lanolin Alcohols, Mineral Oil

  • Questions and Comments?

    1-888-396-2739

  • Label

    CR-5684378 IN MASTER

  • INGREDIENTS AND APPEARANCE
    LEADER BABY SKIN PROTECTANT 
    baby skin protectant ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0079
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM41 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CERESIN (UNII: Q1LS2UJO3A)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0079-185 g in 1 TUBE; Type 0: Not a Combination Product02/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01602/08/2021
    Labeler - Cardinal Health (063997360)
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