Hydrocortisone Cream 1% Antipruritic (anti-itch)

Hydrocortisone Cream 1% Antipruritic (anti-itch)
SPL v3
SPL
SPL Set ID 9ef5a3b2-c36f-162f-e053-2995a90ae2b0
Route
TOPICAL
Published
Effective Date 2019-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Ethylparaben Glycerin Glyceryl Monostearate Stearyl Alcohol Mineral Oil Petrolatum Water Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-20

Description

Hydrocortisone 1%

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone 1%

Uses

For temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:

● eczema ● seborrheic dermatitis ● psoriasis ● insect bites ● poison ivy, oak, sumac ● soaps

● detergents ● cosmetics ● jewelry ● external feminine genital and anal itching

Other uses of this product should be only under the advice and supervision of a doctor

Section 42229-5

Distributed by:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301 USA

Product of PRC

www.trifecta-pharma.com

This product is not manufactured or distributed by Chattem Inc. distributor of Cortizone - 10®

Section 50565-1

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

For external use only

Do not Use:

For the treatment of a diaper rash, consult with doctor

For external genital itching if you have a vaginal discharge, consult doctor

Packaging

Drug Facts

Directions

Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.

Children under 2 years of age: do not use, consult a doctor.

For External and 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.

Active Ingredient

Hydrocortisone 1%

Other Information

● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)

Inactive Ingredients

Ethylparaben, glycerin, glyceryll monostearate, mineral oil, stearyl alcohol, petrolatum, purified water, sodium lauryl sulfate

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 genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use and consult a doctor.
  • do not put this product into the rectum by using fingers or any medicated device or applicator.

Stop Using This Product and Ask A Doctor If
  • conditions worsen
  • symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

Structured Label Content

Uses

For temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:

● eczema ● seborrheic dermatitis ● psoriasis ● insect bites ● poison ivy, oak, sumac ● soaps

● detergents ● cosmetics ● jewelry ● external feminine genital and anal itching

Other uses of this product should be only under the advice and supervision of a doctor

Section 42229-5 (42229-5)

Distributed by:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301 USA

Product of PRC

www.trifecta-pharma.com

This product is not manufactured or distributed by Chattem Inc. distributor of Cortizone - 10®

Section 50565-1 (50565-1)

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Purpose

Anti-Itch

Warnings

For external use only

Do not Use:

For the treatment of a diaper rash, consult with doctor

For external genital itching if you have a vaginal discharge, consult doctor

Packaging

Drug Facts (DRUG FACTS)

Directions

Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.

Children under 2 years of age: do not use, consult a doctor.

For External and 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.

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (Other information)

● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)

Inactive Ingredients (Inactive ingredients)

Ethylparaben, glycerin, glyceryll monostearate, mineral oil, stearyl alcohol, petrolatum, purified water, sodium lauryl sulfate

When Using This Product (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 genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use and consult a doctor.
  • do not put this product into the rectum by using fingers or any medicated device or applicator.

Stop Using This Product and Ask A Doctor If (Stop using this product and ask a doctor if)
  • conditions worsen
  • symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

Advanced Ingredient Data


Raw Label Data

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