Label: LEADER DIAPER RASH CREAM- diaper rash cream cream

  • 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 August 3, 2018

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  • Active Ingredient

    Zinc Oxide 40%

  • Purpose

    Skin Protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps seal out wetness
  • Warnings

    For external use only

    When using this product

    • do not get into 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

    • change wet and soiled diapers promptly
    • cleanse the diaper area, and allow to dry
    • apply paste 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 between 20° to 25°C (68° to 77°F)
    • may stain clothing
  • Inactive Ingredients

    white soft paraffine, COD liver oil, lanoline, talcum, glycerine, sorbitan soquioleate, beeswax, tocopheryl acetate, fragrance.

  • Questions?

    1-888-DYNAREX

  • Label

    CR1189LABEL

  • INGREDIENTS AND APPEARANCE
    LEADER DIAPER RASH CREAM 
    diaper rash cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-981
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    COD LIVER OIL (UNII: BBL281NWFG)  
    LANOLIN (UNII: 7EV65EAW6H)  
    TALC (UNII: 7SEV7J4R1U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LIQUID PETROLEUM (UNII: 6ZAE7X688J)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-981-131 in 1 BOX08/03/2018
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/03/2018
    Labeler - Cardinal Health (097537435)
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