Label: ATOPALM DIAPER RASH- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 June 11, 2012

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  • ATOPALM Diaper Rash Cream


  • Active Ingredient

    Zinc Oxide 10%

  • Purpose

    Skin Protectant

  • Uses

    • Helps treat and prevent diaper rash
    • Protects chafed skin and minor irritation associated with diaper rash
    • Helps seal out wetness.
  • Warnings

    For external use only.

  • When using this product

    • avoid contact with the eyes.
  • Stop use and ask a doctor if

    • Conditions worsen
    • symptoms last more than seven days
    • symptoms clear up and occur within a few days.
  • Keep out of reach of children.

    If swallowed, get medical help immediately or contact a Poison Control Center right away.

  • Directions

    • Change wet and soiled promptly
    • Cleanse the diaper area and allow to dry.
    • Apply cream liberally, as often as necessary, with each diaper change, especially at bedtime or before any prolonged exposure to wet diapers.
  • Other Information

    • store at 15 degrees - 30 degrees C (59 degrees - 86 degrees F)
    • see carton flap or tube crimp for lot number and expiration date
  • Questions or information call toll free:

    1-855-ATOPALM

  • Inactive Ingredients

    WATER, WHITE PETROLATUM, LIGHT MINERAL OIL, SORBITAN SESQUILEATE, WHITE BEESWAX, TALC, STEARIC ACID, DIMETHICONE, ALOE VERA GEL, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA, CHOLESTEROL, PANTHENOL, TOCOPHERYL ACETATE, BENZYL ALCOHOL, SODIUM BENZOATE, FRAGRANCE.
  • ATOPALM Diaper Rash Cream 2oz (51141-0237-2)


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  • INGREDIENTS AND APPEARANCE
    ATOPALM DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0237
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    TALC (UNII: 7SEV7J4R1U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51141-0237-257 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34706/07/2012
    Labeler - NeoPharm Co., Ltd (965502912)
    Registrant - NeoPharm Co., Ltd (965502912)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeoPharm Co., Ltd631101883manufacture
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