Label: CVS DIAPER RASH- zinc oxide and dimethicone 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 January 16, 2023

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  • Drug Facts 

    Active Ingredient 

    Dimethicone,  1% 

    Zinc Oxide,  10%

  • Purpose 

    Skin Protectant 

    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 

    • use after each diaper change. 
    • apply cream liberally to keep moisture away during night time or extended exposure to wetness. 
    • use as needed. 
  • Inactive ingredients 

     Inactive Ingredients: Aloe Barbadensis Leaf Juice, Beeswax, Benzyl Alcohol, Caprylic/Capric Triglyceride, Ceresin Wax (Ozokerite), Cocos Nucifera (Coconut) Oil, Cod Liver Oil (contains Vitamins A & D), Fragrance, Glyceryl Monooleate, Mineral Oil, Paraffin, Propylene Glycol, Sorbitol, Water (purified)

  • Other information 

    Store between 20°-25°C (68°-77°F)

  • Questions ? 

    1800-222-1087

  • Principal Display panel -Tube 

    CVS Diaper Rash Cream with A&D       NDC 51316-625-40

    Dimethicone 1% Skin Protectant 

    Zinc Oxide 10% Skin Protectant 

    NET WT 4.0 oz ( 113g)

    25031192_ZincOxideDiaperCream_wAD_Tube

  • Principal Display Panel -Carton 

    CVS Diaper Rash Cream with A&D NDC 51316-625-40

    Dimethicone 1% Skin Protectant

    Zinc Oxide 10% Skin Protectant

    NET WT 4.0 oz ( 113g)

    5031181_ZincOxideDiaperCream_wAD_Carton

  • INGREDIENTS AND APPEARANCE
    CVS DIAPER RASH 
    zinc oxide and dimethicone ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-625
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CERESIN (UNII: Q1LS2UJO3A)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    GLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-625-401 in 1 CARTON01/01/2023
    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 finalpart34701/01/2023
    Labeler - CVS Health (062312574)
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