Atopalm Moisturizing Hydrocortisone Cream

Atopalm Moisturizing Hydrocortisone Cream
SPL v4
SPL
SPL Set ID da9db299-c18c-4b9e-b036-c52f78e57581
Route
TOPICAL
Published
Effective Date 2015-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Water Glycerin Peg-15 Glyceryl Stearate Isopropyl Myristate Squalane Stearic Acid Butylated Hydroxytoluene Cholesterol Methylparaben Propylparaben Myristoyl/palmitoyl Oxostearamide/arachamide Mea

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-03-17

Description

Active Ingredient Hydrocortisone 1%


Medication Information

Warnings and Precautions

Warnings For external use only.

Indications and 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.

Dosage and 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.

Description

Active Ingredient Hydrocortisone 1%

Section 42229-5

US Patent # US 6221371B1  Distributed by: NeoPharm Co., Ltd., 80 Wood Rd., #212 Camarillo, CA 93010  Made in Korea  75712  LOT and EXP.

Section 44425-7

Other Information



store at room temperature

see end of carton or tube crimp for lot number and expiration date

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9

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.

Section 50567-7

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.

Section 50568-5

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.

Section 50569-3

Ask a doctor or a pharmacist before use if you are using any other hydrocortisone product.

Section 51727-6

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

Section 51945-4

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

Section 53413-1

Questions?  Call 1-855-ATOPALM

Section 55105-1

Purpose

Anti-itch

Section 55106-9

Active Ingredient

Hydrocortisone 1%


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings For external use only.

Section 42229-5 (42229-5)

US Patent # US 6221371B1  Distributed by: NeoPharm Co., Ltd., 80 Wood Rd., #212 Camarillo, CA 93010  Made in Korea  75712  LOT and EXP.

Section 44425-7 (44425-7)

Other Information



store at room temperature

see end of carton or tube crimp for lot number and expiration date

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

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.

Section 50568-5 (50568-5)

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.

Section 50569-3 (50569-3)

Ask a doctor or a pharmacist before use if you are using any other hydrocortisone product.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

Questions?  Call 1-855-ATOPALM

Section 55105-1 (55105-1)

Purpose

Anti-itch

Section 55106-9 (55106-9)

Active Ingredient

Hydrocortisone 1%


Advanced Ingredient Data


Raw Label Data

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