Label: ATOPALM MOISTURIZING HYDROCORTISONE- hydrocortisone 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 9, 2015

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient
    Hydrocortisone 1%

  • PURPOSE

    Purpose

    Anti-itch

  • INDICATIONS & USAGE

    Uses for the temporary relief or itching associated with minor skin irritation, inflammation and rashes due to:
    eczema

    insect bites

    poison ivy, poison oak, or poison sumac
    soaps
    detergents

    jewelry

    seborrheic dermatitis

    psoriasis

    external genital and anal itching Other uses of this product should be only under the advice and supervision of a doctor.

  • WARNINGS

    WarningsFor external use only.

  • ASK DOCTOR/PHARMACIST

    Do not use



    for the treatment of diaper rash.  Consult a doctor

    for external genital itching or if you have a vaginal discharge.  Consult a doctor.

  • WHEN USING

    When using this product


    avoid contact with the eyes
    do not begin the use of any other hydrocortisone product unless you have consulted a doctor
    for external anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly. 

    Do not put this product in rectum by using fingers or any mechanical devise for application.

  • STOP USE

    Stop use and ask a doctor if


    condition worsens or if symptoms persist for more than 7 days or clean up and then occur again within a few days. Stop use and do not begin use of any other hydrocortisone products unless you have consulted a doctor.  Do not exceed recommended daily dosage unless directed by a doctor.

  • ASK DOCTOR

    Ask a doctor or a pharmacist before use if you are using any other hydrocortisone product.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years of age and older


    apply to affected area not more than 3 to 4 times daily   Children under 2 years of age

    Do not use.  Consult a doctor. 
    For external anal itching

    adults: when practical cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. 

    children under 12 years of age with external anal itching, consult a doctor.

  • STORAGE AND HANDLING

    Other Information

    store at room temperature
    see end of carton or tube crimp for lot number and expiration date

  • INACTIVE INGREDIENT

    Inactive Ingredients  Water, Glycerin, Cetyl Alcohol, PEG-15 Glyceryl Stearate, Glyceryl Stearate, Isopropyl Myristate, Squalane, Stearic Acid, BHT, Cholesterol, Myristoyl/Palmitoyl Oxostearamide/ Arachamide MEA, Methylparaben, Propylparaben

  • QUESTIONS

    Questions?  Call 1-855-ATOPALM

  • SPL UNCLASSIFIED SECTION

    US Patent # US 6221371B1  Distributed by: NeoPharm Co., Ltd., 80 Wood Rd., #212 Camarillo, CA 93010  Made in Korea  75712  LOT and EXP.

  • PRINCIPAL DISPLAY PANEL

    Maximum Strength

    plus US Patented Technology

    1% Hydrocortisone

    ATOPALM TM

    MOISTURIZING HYDROCORTISONE CREAM

    WITH US PATENTED M L E TECHNOLOGY

    Relieves Itching and Redness Fast!

    Provides Temporary Relief and Visibly Healthier Looking Skin

    Maximum Strength

    medicine without a prescription for temporary relief of your worst itch symptoms.

    ATOPALM TM

    Relieves itches due to: Dry Skin, Psoriasis, Seborrheic Dermatitis, Rashes

    Net Wt. 1 oz/ 28.3 g

  • PRINCIPAL DISPLAY PANEL


    Atopalm Inner

    Atopalm Outer

  • INGREDIENTS AND APPEARANCE
    ATOPALM MOISTURIZING HYDROCORTISONE  
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-6000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-15 GLYCERYL STEARATE (UNII: 91245SPD5K)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    SQUALANE (UNII: GW89575KF9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51141-6000-11 in 1 CARTON
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/17/2011
    Labeler - NeoPharm Co., Ltd. (965502912)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeoPharm Co., Ltd.631101883manufacture(51141-6000)