Label: DIAPER RASH- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

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 December 30, 2020

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  • Active ingredient

    Zinc Oxide 10%

  • Purpose

    Skin Protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps protect skin from wetness
    • helps prevent and temporarily protect chafed, chapped, cracked or windburned skin lips
  • Warnings

    For external use only

    Do not use

    over deep or puncture wounds, infections or lacerations

    When using this product

    avoid contact with the eyes

    Stop use and ask a doctor

    if condition worsens or does not improve within 7 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 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
    • Lot No and Exp Date: see box or see crimp of tube
  • Inactive ingredients

    Talc, Vacillin, Bees wax, Demethicone, Liquid paraffin, Tocopherol acetate, Sesquioleate sorbitan, Aloe vera gel, Methylparaben, Propylparaben, Purified water

  • Package label

    Diaper Rash Cream image of product carton

  • INGREDIENTS AND APPEARANCE
    DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0502
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    AMPICILLIN TRIHYDRATE (UNII: HXQ6A1N7R6)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0502-21 in 1 BOX08/25/2011
    157 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:67510-0502-41 in 1 BOX08/25/2011
    2114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/25/2011
    Labeler - Kareway Product, Inc. (121840057)
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