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 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)

Revised: 6/2015
Document Id: 74b83355-8af7-440f-9c35-36660fc5d474
Set id: da9db299-c18c-4b9e-b036-c52f78e57581
Version: 4
Effective Time: 20150609
 
NeoPharm Co., Ltd.