ATOPALM Moisturizing Hydrocortisone

Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: NeoPharm Co., Ltd.
NDC Code: 51141-6000

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.

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 MOISTURIZING HYDROCORTISONE  
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-6000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
PEG-15 GLYCERYL STEARATE 
ISOPROPYL MYRISTATE 
SQUALANE 
STEARIC ACID 
BUTYLATED HYDROXYTOLUENE 
CHOLESTEROL 
METHYLPARABEN 
PROPYLPARABEN 
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA 
Packaging
#Item CodePackage Description
1NDC:51141-6000-11 TUBE (TUBE) in 1 CARTON
128.3 g in 1 TUBE
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/FEIOperations
NeoPharm Co., Ltd.631101883manufacture

Revised: 11/2011
 
NeoPharm Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)