Label: LEADER DIAPER RASH- zinc oxide ointment

  • 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 October 11, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient                                                                       Purpose

    Zinc oxide, 40% .....................................................................Skin protectant

  • PURPOSE

    Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps protect skin from wetness
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    over deep or puncture wounds, infections or lacerations

  • WHEN USING

    When using this product avoid contact with the eyes

  • STOP USE

    Stop use and ask a doctor if condition worsens or does not improve within 7 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.

  • INDICATIONS & USAGE

    Directions

    • 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
  • STORAGE AND HANDLING

    Other information

    • store at 20o to 25oC (68o to 77oF)
    • Lot No. and Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    butylhydroxyanisole, lavendar oil, liquid paraffin, methylparaben, polysorbate 60, purified lanolin, sorbitan monostearate, squalane, talc, tocopherol acetate, water, white petrolatum

  • DOSAGE & ADMINISTRATION

    Distributed By Cardinal Health

    Dublin, Ohio 43017

    www.myleader.com

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LEADER DIAPER RASH 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-637
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.40 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    LANOLIN (UNII: 7EV65EAW6H)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    SQUALANE (UNII: GW89575KF9)  
    TALC (UNII: 7SEV7J4R1U)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-637-261 in 1 CARTON10/11/2016
    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 finalpart34701/20/2012
    Labeler - CARDINAL HEALTH (097537435)
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