Label: CVS HEALTH DIAPER RASH- zinc oxide cream

  • NDC Code(s): 66902-449-04
  • Packager: NATURAL ESSENTIALS, INC.
  • 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 April 1, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc Oxide (13%)

  • 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
    • allow to dry
    • apply cream 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 20° to 25°C (68° to 77°F)
    • protect from freezing
    • may stain clothing
  • Inactive ingredients

    Water, Mineral Oil (Paraffinium Liquidum), Petrolatum, Beeswax, Sorbitan Sesquioleate, Glycerin, Microcrystalline Wax, Dimethicone, Phenoxyethanol, Ethylhexylglycerin, Magnesium Sulfate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Potassium Hydroxide.

  • Principal Display Panel – Box Label

    CVS

    Health®

    Compare to the active
    ingredient in Desitin® Daily
    Defense Diaper Rash Cream*

    Cream

    Diaper
    Rash
    Cream

    ZINC OXIDE 13%

    Skin protectant

    Daily use for
    diaper rash

    Fast acting

    Paraben Free

    Fragrance free

    NET WT 4 OZ (113 g)

    Principal Display Panel – Box Label
  • Principal Display Panel – Tube Label

    CVS

    Health®

    Cream

    Diaper
    Rash
    Cream

    ZINC OXIDE 13%

    Skin protectant

    Daily use for
    diaper rash

    Fast acting

    Paraben Free

    Fragrance free

    NET WT 4 OZ (113 g)

    Principal Display Panel – Tube Label
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-449
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Cation - UNII:13S1S8SF37) Zinc Cation14.7 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-449-041 in 1 BOX04/01/2020
    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 finalpart34704/01/2020
    Labeler - NATURAL ESSENTIALS, INC. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-449)
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