Avedana ®

Avedana ®
SPL v9
SPL
SPL Set ID f4d62ccb-4add-44ed-9798-2c37c739fa08
Route
TOPICAL
Published
Effective Date 2021-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (0.0102 g)
Inactive Ingredients
Petrolatum Mineral Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-02-03

Description

Hydrocortisone, USP 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone, USP 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, poison sumac, soaps, jewelry, detergents, cosmetics, psoriasis, seborrheic dermatitis, for external genital, feminine and anal itching, other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

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, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before applicaion of this product.

Children under 12 years of age: consult a doctor.

Do Not Use

for external feminine itching if you have a vaginal discharge.  Consult a doctor.

for the treatment of diaper rash.  Consult a doctor.

Active Ingredient

Hydrocortisone, USP 1%

Other Information

Storage temperature: not to exceed 30 oC (86 oF).

Before using any medication, read all label directions.  Keep carton, it contains important information.

Inactive Ingredients

mineral oil, white petrolatum

When Using This Product

avoid contact with the eyes, do not begin the use of any other hydrocortisone product unless directed by a doctor, for external anal itching: do not use more than directed unless directed by a doctor, do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop Use and Ask A Doctor If

symptoms last for more than 7 days, the condition gets worse, symptoms clear up and occur again in a few days, rectal bleeding occurs, consult doctor promptly

Keep Out of Reach of Children.

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

Avedana® Maximum Strength Hydrocortisone Ointment | 1oz Tube Label

Avedana® Maximum Strength Hydrocortisone Ointment | 1oz Carton Label


Structured Label Content

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, jewelry, detergents, cosmetics, psoriasis, seborrheic dermatitis, for external genital, feminine and anal itching, other uses of this product should be only under the advice and supervision of a doctor

Purpose

Anti-itch

Warnings

For external use only

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, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before applicaion of this product.

Children under 12 years of age: consult a doctor.

Do Not Use (Do not use)

for external feminine itching if you have a vaginal discharge.  Consult a doctor.

for the treatment of diaper rash.  Consult a doctor.

Active Ingredient

Hydrocortisone, USP 1%

Other Information (Other information)

Storage temperature: not to exceed 30 oC (86 oF).

Before using any medication, read all label directions.  Keep carton, it contains important information.

Inactive Ingredients

mineral oil, white petrolatum

When Using This Product (When using this product)

avoid contact with the eyes, do not begin the use of any other hydrocortisone product unless directed by a doctor, for external anal itching: do not use more than directed unless directed by a doctor, do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms last for more than 7 days, the condition gets worse, symptoms clear up and occur again in a few days, rectal bleeding occurs, consult doctor promptly

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Avedana® Maximum Strength Hydrocortisone Ointment | 1oz Tube Label

Avedana® Maximum Strength Hydrocortisone Ointment | 1oz Carton Label


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)