Label: ATOPALM MAXIMUM STRENGTH ANTI-ITCH- hydrocortisone 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 November 9, 2011

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

  • Active Ingredient

    Active Ingredient...........................Purpose
    Hydrocortisone 1%.......................Anti-Itch

  • Uses

    for the temporary relief of itching associated with minor skin irritations, 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

    For external use only.

  • Do not use

    - for the treatment of diaper rash, consult a doctor  - for external genital itching, if you have a vaginal discharge, consult a doctor

  • 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 and ask a doctor if

    - condition worsens - symptoms persist for more than 7 days or clear up and occur again within a few days.

  • Keep out of reach of children

    Keep out of reach of children.

  • Other Safety Information

    If swallowed, get medical help or call a Poison Control Center immediately.

  • 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, or 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 & Handling

    - store at 20° – 25°C (68° – 77°F)  - see end of carton or tube crimp for lot number and expiration date

  • Inactive Ingredients

    Petrolatum, Mineral Oil, Cetyl Alcohol, Stearic Acid, Beeswax, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, Cholesterol, Methylparaben, Propylparaben

  • Questions or information

    Questions or information call toll free: 1-855- ATOPALM

  • Purpose

    Anti-Itch

  • Description

    US Patent # US 6221371B1  Distributed by: Neopharm, USA, 1 Oyster Bay Drive, Rumson, NJ 07760 Made in Korea  Batch/Lot # / Exp. Date

  • PRINCIPAL DISPLAY PANEL

    Maximum Strength Therapy  available without a prescription  Anti-Itch Ointment  ATOPALM  MAXIMUM STRENGTH ANTI-ITCH OINTMENT  US Patented M L E Moisturizing Technology  Net Wt. 1 oz /28.3 g  1% Hydrocortisone  Active Ingredient Hydrocortisone 1%  Uses: for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak or poison sumac, soaps, detergents, 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 For external use only. Do not use - For the treatment of diaper rash, consult a doctor - For external genital itching, if you have a vaginal discharge, consult a doctor. When using this product - avoid contact with 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 into the rectum by using fingers or any mechanical devise or applicator. Stop use and ask a doctor if - condition worsens - symptoms persist for more than 7 days or clear up and occur again with a few days. Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center immediately.  Directions: Adults and children 2 years of age or 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, or 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. Other information: store at 20° – 25°C (68° – 77°F) See end of carton or tube crimp for lot number and expiration date.  Questions or information call toll free: 1-855 ATOPALM  Distributed by: Neopharm, USA, 1 Oyster Bay Drive, Rumson, NJ 07760  Made in Korea #75722

  • PRINCIPAL DISPLAY PANEL

    Maximum Strength Therapy  without a prescription  1% Hydrocortisone Anti-Itch Ointment  ATOPALM  MAXIMUM STRENGTH ANTI-ITCH OINTMENT  US Patented M L E Moisturizing Technology  Fast, temporary relief of pain, itching and redness from insect bites and skin irritations associated with Poison Ivy, Oak, Sumac, Eczema and Psoriasis. Leaves Skin Looking Visibly Healthier, Softer, Smoother.  Maximum Strength without a prescription  ATOPALM  RAPID RELIEF Rapid Relief of Itching and Redness

  • PRINCIPAL DISPLAY PANEL

    Rapid Relief of Itching and Redness  ATOPALM  MAXIMUM STRENGTH ANTI-ITCH OINTMENT  US Patented M L E Moisturizing Technology  Net Wt. 1 oz /28.3 g  1% Hydrocortisone  ATOPALM  MAXIMUM STRENGTH ANTI-ITCH OINTMENT  US Patented M L E Moisturizing Technology  8  57811 00222  4  Rapid Relief Anti-Itch Ointment

  • PRINCIPAL DISPLAY PANEL

    ATOPALM  RAPID RELIEF ANTI-ITCH OINTMENT  Fast Temporary Relief of Pain and Itching from Insect Bites, Poison Ivy, Oak and Sumac, Psoriasis, External Genital and Anal Itching.  US Patent # US 6221371B1 Distributed by: Neopharm, USA, 1 Oyster Bay Drive, Rumson, NJ 07760 Made in Korea  75722  Batch/Lot # / Exp. Date

  • Product Package Inner Label

    Atopalm Maximum Strength Inner Package

  • Product Package Outer Label 1

    Atopalm Maximum Strength Outer Package 1

  • Product Package Outer Label 2

    Atopalm Maximum Strength Outer Package 2

  • Product Package Outer Label 3

    Atopalm Maximum Strength Outer Package 3

  • INGREDIENTS AND APPEARANCE
    ATOPALM MAXIMUM STRENGTH ANTI-ITCH  
    hydrocortisone ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-6010
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51141-6010-11 in 1 CARTON
    128.3 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34811/04/2011
    Labeler - NeoPharm Co., Ltd. (965502912)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeoPharm Co., Ltd.631101883manufacture