ATOPALM MOISTURIZING HYDROCORTISONE - hydrocortisone cream

Spojené štáty - angličtina - NLM (National Library of Medicine)

Kúpte ho teraz

Aktívna zložka:
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Dostupné z:
NeoPharm Co., Ltd.
INN (Medzinárodný Name):
HYDROCORTISONE
Zloženie:
HYDROCORTISONE 1 g in 100 g
Spôsob podávania:
TOPICAL
Typ predpisu:
OTC DRUG
Terapeutické indikácie:
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. 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.
Stav Autorizácia:
OTC monograph not final
Číslo povolenia:
51141-6000-1

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.

----------

ATOPALM Moisturizing Hydrocortisone Cream

Active Ingredient

Hydrocortisone 1%

Purpos e

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

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

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:51141-6 0 0 0

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

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

PEG-15 GLYCERYL STEARATE (UNII: 9 1245SPD5K)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

NeoPharm Co., Ltd.

SQ UALANE (UNII: GW8 9 575KF9 )

STEARIC ACID (UNII: 4ELV7Z6 5AP)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

CHO LESTERO L (UNII: 9 7C5T2UQ7J)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:51141-6 0 0 0 -1

1 in 1 CARTON

1

28 .3 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 3/17/20 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 (51141-6 0 0 0 )

Revised: 6/2015

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