Hydrocortisone HYDROCORTISONE TRIFECTA PHARMACEUTICALS USA LLC FDA Approved Uses 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.
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Substance Hydrocortisone
Route
TOPICAL
Applications
M017
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Hydrocortisone 1%
Inactive Ingredients
Inactive ingredients Light Mineral Oil Petrolatum
Strengths
1 %
Treats Conditions
Uses 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
Pill Appearance
Color: white

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0070038667001
UNII
WI4X0X7BPJ
Packaging

Packaging AWGAS Hydrocortisone Ointment 1 percent 1oz 081023 CDER

Package Descriptions
  • Packaging AWGAS Hydrocortisone Ointment 1 percent 1oz 081023 CDER

Overview

Uses 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.

Indications & Usage

Uses 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.

Dosage & Administration

Directions Adults and children 2 years 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 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.

Warnings & Precautions
Warnings ● for external use only
Purpose

Purpose Anti-itch

Do Not Use

Do Not Use 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

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

Stop Use & Ask a Doctor

Stop using this product and ask a doctor if Conidtions 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 any other hydrocortisone product unless directed by a doctor.

Keep Out of Reach of Children

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

Storage & Handling

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

Questions

Questions: Call 1-800-883-0085


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