Hydrocortisone 1% Gerigentle

Hydrocortisone 1% Gerigentle
SPL v3
SPL
SPL Set ID 0adfa2f0-9758-5c54-e063-6294a90a461f
Route
TOPICAL
Published
Effective Date 2013-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Cetostearyl Alcohol Chlorocresol Ceteth-20 Edetate Disodium Mineral Oil Propylene Glycol Water Sodium Metabisulfite Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-23

Description

Hydrocortisone Acetate USP (1% w/w)

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone Acetate USP (1% w/w)

Uses

■ for temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor

Section 50565-1

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

Warnings

For external use only

Directions

■ adults and children over 2 years of age

■ apply evenly to affected area no more than 3 to 4 times daily

■ children under 2 years of age■ do not use, consult a doctor

Adults

■ when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly

■ gently dry, patting or blotting with bathroom tissue or soft cloth before applying

■ apply externally to the area up to 6 times a daily or after a bowel movement

■ after application discard pad

■ do not flush in toilet

Do Not Use

■ in the eyes ■ for diaper rash ■ if you have vaginal discharge ■ more than the recommended dosage

Package Label

Active Ingredient

Hydrocortisone Acetate USP (1% w/w)

Other Information

■ store at 20-25C (68-77F) 

■ avoid excessive heat and humidity

Inactive Ingredients

cetostearyl alcohol, chlorocresol, ceteth-20, edetate disodium, liquid paraffin, propylene glycol, purified water, sodium metabisulphite, white soft paraffin

Ask A Doctor Before Use

■ if you are pregnant or breast feeding

Stop Use and Ask A Doctor If

■ the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again wihin a few days


Structured Label Content

Uses

■ for temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor

Section 50565-1 (50565-1)

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

Purpose

Anti-itch

Warnings

For external use only

Directions

■ adults and children over 2 years of age

■ apply evenly to affected area no more than 3 to 4 times daily

■ children under 2 years of age■ do not use, consult a doctor

Adults

■ when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly

■ gently dry, patting or blotting with bathroom tissue or soft cloth before applying

■ apply externally to the area up to 6 times a daily or after a bowel movement

■ after application discard pad

■ do not flush in toilet

Do Not Use (Do not use)

■ in the eyes ■ for diaper rash ■ if you have vaginal discharge ■ more than the recommended dosage

Package Label

Active Ingredient

Hydrocortisone Acetate USP (1% w/w)

Other Information (Other information)

■ store at 20-25C (68-77F) 

■ avoid excessive heat and humidity

Inactive Ingredients

cetostearyl alcohol, chlorocresol, ceteth-20, edetate disodium, liquid paraffin, propylene glycol, purified water, sodium metabisulphite, white soft paraffin

Ask A Doctor Before Use (Ask a doctor before use)

■ if you are pregnant or breast feeding

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

■ the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again wihin a few days


Advanced Ingredient Data


Raw Label Data

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