87083-002 Update Change M017

87083-002 Update Change M017
SPL v2
SPL
SPL Set ID 41bad9f3-f1a7-e92c-e063-6394a90ad0ba
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, (+)- Carbomer 940 Allantoin Petrolatum Edetate Calcium Disodium Glyceryl Monostearate Peg-60 Stearate Water Dimethicone Mineral Oil Phenoxyethanol Sodium Hydroxide 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

Temporarily relieves the itching and discomfort associated witch minor skin irritations, rashes,and inflammation,anddue to eczema.

Stop Use

Condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor.

Warnings

For external use only.Other uses of this product should only be under the advice and supervision of a doctor.

Ask Doctor

do not begin use of any other hydrocortisone product unless you have asked a doctor.

Directions

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

Do Not Use

for the treatment of diaper rash.Consult a doctor.

When Using

·Avoid contact with eyes

·Do not use more than directed

·Less told to do so by a doctor

Active Ingredient

Hydrocortisone 1%

Other Information

Store at room temperature 15-30℃(59-86℉)

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

Temporarily relieves the itching and discomfort associated witch minor skin irritations, rashes,and inflammation,anddue to eczema.

Purpose

Anti-itch

Stop Use

Condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor.

Warnings

For external use only.Other uses of this product should only be under the advice and supervision of a doctor.

Ask Doctor

do not begin use of any other hydrocortisone product unless you have asked a doctor.

Directions

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

Do Not Use (Do not use)

for the treatment of diaper rash.Consult a doctor.

When Using

·Avoid contact with eyes

·Do not use more than directed

·Less told to do so by a doctor

Active Ingredient

Hydrocortisone 1%

Other Information (Other information)

Store at room temperature 15-30℃(59-86℉)

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

All Sections (JSON)