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Name:Atopalm Moisturizing Hydrocortisone
Manufacturer:Neopharm Co., Ltd.
Category:Over-the-counter (OTC) Marketed Drugs


ATOPALM Moisturizing Hydrocortisone Cream

ATOPALM MOISTURIZING HYDROCORTISONE  - hydrocortisone cream 
NeoPharm Co., Ltd.

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.

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ATOPALM Moisturizing Hydrocortisone Cream

Active Ingredient
Hydrocortisone 1%

Purpose

Anti-itch

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.

WarningsFor external use only. 

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

Keep out of reach of children. If swallowed, get medical help or contact 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. 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.

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

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?  Call 1-855-ATOPALM

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

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


Atopalm Inner

Atopalm Outer


ATOPALM MOISTURIZING HYDROCORTISONE 
hydrocortisone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51141-6000
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
PEG-15 GLYCERYL STEARATE  
ISOPROPYL MYRISTATE  
SQUALANE  
STEARIC ACID  
BUTYLATED HYDROXYTOLUENE  
CHOLESTEROL  
METHYLPARABEN  
PROPYLPARABEN  
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51141-6000-1 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 28.3 g in 1 TUBE This package is contained within the CARTON (51141-6000-1)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 03/17/2011

Labeler - NeoPharm Co., Ltd. (028612667)

Revised: 04/2011 NeoPharm Co., Ltd.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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