Label: DIAPER RASH CREAM HAPPY CHEEKS- diaper rash happy cheeks cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • ACTIVE INGREDIENT

    Zinc Oxide 14.9%

  • PURPOSE

    Skin Protectorant

  • Uses

    Helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash. 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 immediately

  • DOSAGE & ADMINISTRATION

    Change wet and soild diapers promptly, cleanse the diaper area, and allow to dry. Shake well before use. Spray 4-6 inches away from the skin. Spray product liberally as often as needed, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. No need to rub in

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Juice, Bentonite, Butyrospermum Parkii (Shea) Butter, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Coco Glucoside, Glycerin, Glyceryl Oleate, Glyceryl Rosinate, Microcrystalline Cellulose, Olea Europaea (Olive) Fruit Oil, Olea Europaea (Olive) Oil Unsaponifiables, Propanediol, Ricinus Communis (Castor) Seed Oil, Water

  • OTHER SAFETY INFORMATION

    Protect this product from excessive heat and direct sun • May stain some fabrics and surfaces

  • QUESTIONS

    212-627-0377 M-F 9am to 5pm EST

  • PRINCIPAL DISPLAY PANEL

    PDP DFP

  • INGREDIENTS AND APPEARANCE
    DIAPER RASH CREAM HAPPY CHEEKS 
    diaper rash happy cheeks cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84568-549
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    WATER (UNII: 059QF0KO0R)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)  
    CELLULOSE GUM (UNII: K679OBS311)  
    CETEARYL ALCOHOL (UNII: 2DMT128M1S)  
    RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    COCO-GLUCOSIDE (UNII: ICS790225B)  
    GLYCERYL ROSINATE (UNII: SD112V492J)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84568-549-1589 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/13/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/13/2024
    Labeler - Dimples Bath Co. LLC (119296438)
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