ATOPALM MOISTURIZING HYDROCORTISONE- hydrocortisone cream

ATOPALM Moisturizing Hydrocortisone by

Drug Labeling and Warnings

ATOPALM Moisturizing Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by NeoPharm Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ATOPALM MOISTURIZING HYDROCORTISONE  
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51141-6000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51141-6000-1	1 in 1 CARTON
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product

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. (965502912)

Establishment
Name	Address	ID/FEI	Business Operations
NeoPharm Co., Ltd.		631101883	manufacture(51141-6000)