Label: DIAPER RASH- zinc oxide cream

  • NDC Code(s): 63941-318-04
  • Packager: Valu Merchandisers, Co.
  • 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 February 8, 2023

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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
    • helps seal out wetness
  • Warnings

    For external and/or intrarectal 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 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
    • clean the diaper area
    • allow to dry
    • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged
  • Other information

    store at 20 to 25C (68 to 77F)

  • Inactive ingredients

    butylated hydroxytoluene, cod liver oil, fd&c yellow #4, lanolin, methyl paraben, paraffin wax, purified water, talc powder, white petrolatum

  • Questions or comments?

    Call toll free: 1-800-883-0085

  • Package label

    Diaper Rash Cream

    carton

  • INGREDIENTS AND APPEARANCE
    DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-318
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE400 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    TALC (UNII: 7SEV7J4R1U)  
    WATER (UNII: 059QF0KO0R)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-318-041 in 1 BOX01/30/2012
    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 finalpart34701/30/2012
    Labeler - Valu Merchandisers, Co. (868703513)
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