ATOPALM MAXIMUM STRENGTH ANTI-ITCH

Main information

  • Trade name:
  • ATOPALM MAXIMUM STRENGTH ANTI-ITCH - hydrocortisone ointment
  • Composition:
  • HYDROCORTISONE 1 g in 100 g
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ATOPALM MAXIMUM STRENGTH ANTI-ITCH  - hydrocortisone ointment
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • 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. - for the treatment of diaper rash, consult a doctor  - for external genital itching, if you have a vaginal discharge, consult a doctor - condition worsens - symptoms persist for more than 7 days or clear up and occur again within a few days. Anti-Itch

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 51141-6010-1
  • Last update:
  • 30-05-2019

Summary of Product characteristics: dosage, interactions, side effects

ATOPALM MAXIMUM STRENGTH ANTI-ITCH - hydrocortisone ointment

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 Maximum Strength Anti-Itch Ointment

Active Ingredient

Active Ingredient...........................Purpose

Hydrocortisone 1%.......................Anti-Itch

Us es

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

Purpos e

Anti-Itch

Des cription

US Patent # US 6221371B1 Distributed by: Neopharm, USA, 1 Oyster Bay Drive, Rumson, NJ 07760

Made in Korea Batch/Lot # / Exp. Date

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

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

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

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

ATOPALM MAXIMUM STRENGTH ANTI-ITCH

hydrocortisone ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:51141-6 0 10

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO CO RTISO NE (UNII: WI4X0 X7BPJ) (HYDROCORTISONE - UNII:WI4X0 X7BPJ)

HYDROCORTISONE

1 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

MINERAL O IL (UNII: T5L8 T28 FGP)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

MYRISTO YL/PALMITO YL O XO STEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8 G7)

CHO LESTERO L (UNII: 9 7C5T2UQ7J)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

NeoPharm Co., Ltd.

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:51141-6 0 10 -1

1 in 1 CARTON

1

28 .3 g in 1 TUBE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt348

11/0 4/20 11

Labeler -

NeoPharm Co., Ltd. (965502912)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Neo Pharm Co ., Ltd.

6 3110 18 8 3

ma nufa c ture

Revised: 11/2011