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

Purpose

Anti-itch

Description

Hydrocortisone 1%


Medication Information

Warnings

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

Purpose

Anti-itch

Directions

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

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.

Description

Hydrocortisone 1%

Principal Display Panel

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.

Ask Doctor

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

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%

Keep Out of Reach of Children

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


Structured Label Content

Warnings

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

Purpose

Anti-itch

Directions

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

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)

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.

Ask Doctor

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

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%

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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