Label: CVS HEALTH 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 August 3, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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

    • avoid contact with 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 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 15° - 30°C (59° - 86°F)

  • Inactive ingredients

    Petrolatum, Glycerin, Cod Liver Oil, Sorbitan Sesquioleate, Lanolin, Beeswax, Talc, Tocopheryl Acetate, Fragrance

  • Principal Display Panel - Carton Label

    Diaper Rash 

    Ointment

    40% Zinc Oxide Skin Protectant

    • Promotes healing

    • Relieves chafing

    • Paraben & phthalate free

    Helps Treat and
    Prevent Diaper Rash

    24 Packettes

    NET WT. 0.10 oz(3G) Each

    Total -2.4 oz (68G)

    Principal Display Panel - Carton Label

  • Principal Display Panel - Packet Label

    CVS Health

    Diaper Rash
    Ointment

    40% Zinc Oxide Skin Protectant

    • Promotes Healing 
    • Relieves chafing 
    • Paraben and phthalate free

    NET WT 0.10 oz(3G)

    Principal Display Panel - Packet Label
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH DIAPER RASH 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-702
    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
    COD LIVER OIL (UNII: BBL281NWFG)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    TALC (UNII: 7SEV7J4R1U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-702-1024 in 1 CARTON06/30/2018
    13 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/30/2018
    Labeler - CVS Health (062312574)
    Registrant - Sheffield Pharmaceuticals, LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals, LLC151177797MANUFACTURE(69842-702)
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