Label: DIAPER RASH- dimethicone, zinc oxide cream

  • 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 May 21, 2014

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  • Active ingredient

    Dimethicone, 1%
    Zinc Oxide, 10%

  • Purpose

    Diaper rash cream

  • 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 diaper cream liberally to keep moisture away during nighttime or extended exposure to wetness
    •
    use as needed
  • Other Information

    Store between 20° to 25°C (68° to 77°F)

  • Inactive Ingredients

    aloe barbadensis extract, benzyl alcohol, beeswax, caprylic/capric triglyceride, coconut oil, cod liver oil (contains vitamin A & vitamin D), fragrance, glyceryl oleate citrate, ozokerite, paraffin, paraffin oil, propylene glycol, sorbitol, water.

  • Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895© 2014 CVS/pharmacyCVS.com® 1-800-SHOP CVSManufactured in IsraelV-31338BD827 17 C1 CVS® Quality Money Back Guarantee

  • Package/Label Principal Display Panel - Carton Label

    CVS pharmacy™

    Zinc Oxide
    Diaper Cream
    Diaper Rash & All Purpose Skin Protectant

    •
    Soothes red, irritated skin & promotes natural healing
    •
    Contains vitamins A & D
    •
    Easy to apply

    Compare to the active ingredients in A+D® Diaper Rash Cream*

    *This product is not manufactured or distributed by MSD Consumer Care, Inc., owner of the registered trademark A+D®.

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    DIAPER RASH 
    dimethicone, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-827
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ROYAL JELLY (UNII: L497I37F0C)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-827-121 in 1 CARTON
    1113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2014
    Labeler - CVS Pharmacy (062312574)
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