ATOPALM MAXIMUM STRENGTH ANTI-ITCH- hydrocortisone ointment

Atopalm Maximum Strength Anti-Itch by

Drug Labeling and Warnings

Atopalm Maximum Strength Anti-Itch 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...........................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

Product Package Outer Label 1

Product Package Outer Label 2

Product Package Outer Label 3

INGREDIENTS AND APPEARANCE

ATOPALM MAXIMUM STRENGTH ANTI-ITCH  
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51141-6010
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51141-6010-1	1 in 1 CARTON
1		28.3 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	11/04/2011

Labeler - NeoPharm Co., Ltd. (965502912)

Establishment
Name	Address	ID/FEI	Business Operations
NeoPharm Co., Ltd.		631101883	manufacture