87083-003 Update Change M107

87083-003 Update Change M107
SPL v2
SPL
SPL Set ID 41bb9ced-dde4-2998-e063-6394a90a8159
Route
TOPICAL
Published
Effective Date 2025-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Menthol, (+)- Mineral Oil Carbomer 940 Phenoxyethanol Allantoin Sodium Hydroxide Edetate Calcium Disodium Petrolatum Water Glyceryl Monostearate Dimethicone Peg-60 Stearate Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-22

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

Use

·Cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown.

·Cures most jock itch and ringworm.

·Relieves itching, burning, cracking, and scaling which accompany these conditions.

Stop Use

too much irritation occurs or irritation gets worse

Warnings

For external use only.

Ask Doctor

too much irritation occurs or irritation gets worse

Directions

For athlete's foot and ring worm: use daily for 4 weeks.Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise child ren in the use of this product.This product is not effective for the treatment of ring worm of the scalp or nails. For athlete's foot: pay special attention to spaces between the toes,wear well-fitting, ventilated shoes, and changeshoes and socks at least once daily. To prevent athlete's foot, apply once or twice daily (morning and/or night). Apply to skin around the nail and cuticle.

Do Not Use

·on nails or scalp

·in or near the mouth or the eyes

·for vaginal yeast infections

When Using

do not get into the eyes. If eye contact occurs, rinse thoroughly with water

Active Ingredient

Hydrocortisone 1%

Other Information

·do not use if seal on tube is broken or not visible

·store between 20° to 25°C (68° to 77℉)

Inactive Ingredients

PEG-100 stearate, Glycerol stearate, Cetyl stearol,Mineral fat, Ice flake, Menthol, Mineral oil, water, Carbomer 940, Chlorphenylate, Phenoxyethanol, EDTA- disodium, Allantoin, Sodium hydroxide,Essence, Polydimethylsiloxane.

Principal Display Panel

Keep Out of Reach of Children

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


Structured Label Content

Use

·Cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown.

·Cures most jock itch and ringworm.

·Relieves itching, burning, cracking, and scaling which accompany these conditions.

Purpose

Anti-itch

Stop Use

too much irritation occurs or irritation gets worse

Warnings

For external use only.

Ask Doctor

too much irritation occurs or irritation gets worse

Directions

For athlete's foot and ring worm: use daily for 4 weeks.Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise child ren in the use of this product.This product is not effective for the treatment of ring worm of the scalp or nails. For athlete's foot: pay special attention to spaces between the toes,wear well-fitting, ventilated shoes, and changeshoes and socks at least once daily. To prevent athlete's foot, apply once or twice daily (morning and/or night). Apply to skin around the nail and cuticle.

Do Not Use (Do not use)

·on nails or scalp

·in or near the mouth or the eyes

·for vaginal yeast infections

When Using

do not get into the eyes. If eye contact occurs, rinse thoroughly with water

Active Ingredient

Hydrocortisone 1%

Other Information (Other information)

·do not use if seal on tube is broken or not visible

·store between 20° to 25°C (68° to 77℉)

Inactive Ingredients (Inactive ingredients)

PEG-100 stearate, Glycerol stearate, Cetyl stearol,Mineral fat, Ice flake, Menthol, Mineral oil, water, Carbomer 940, Chlorphenylate, Phenoxyethanol, EDTA- disodium, Allantoin, Sodium hydroxide,Essence, Polydimethylsiloxane.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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.


Advanced Ingredient Data


Raw Label Data

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