Label: A AND D- dimethicone and zinc oxide cream

  • NDC Code(s): 11523-1314-1, 11523-1314-2, 11523-1314-3
  • Packager: Bayer HealthCare LLC.
  • 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 September 8, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

    Dimethicone, Zinc Oxide

    Active ingredientsPurpose
    Dimethicone 1%Diaper rash Cream
    Zinc Oxide 10%Diaper rash Cream
  • Uses

    • helps treat and prevent diaper rash
    • protects minor skin irritation 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, and 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 between 20°C to 25 °C ( 68° to 77°F)

  • Inactive Ingredients

    Aloe barbadensis extract, benzyl alcohol, coconut oil, cod liver oil ( contains vitamin A & Vitamin D), fragrance, glyceryl oleate, light mineral oil, ozokerite, paraffin, propylene glycol, sorbitol, synthetic beeswax, water

  • PRINCIPAL DISPLAY PANEL - 113g Carton

    New Look

    A+D®

    Treat

    Diaper Rash Cream

    with Dimethicone and Zinc Oxide

    • Works on contact to help treat & calm diaper rash
    • Allows skin to heal naturally

    PEDIATRICIAN RECOMMENDED

    PARABEN-FREE

    DYE-FREE

    MOISTURIZING WITH ALOE

    NET WT

    1.5 OZ (42.5 G)

    Carton 1.5 oz.

  • INGREDIENTS AND APPEARANCE
    A AND D 
    dimethicone and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-1314
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE11.09 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE110.09 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Colorwhite (White cream) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-1314-21 in 1 CARTON12/25/200910/31/2019
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11523-1314-31 in 1 CARTON12/25/200905/09/2023
    285 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:11523-1314-11 in 1 CARTON12/25/200905/11/2021
    342.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/25/2009
    Labeler - Bayer HealthCare LLC. (112117283)
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