SPL v4
SPL
SPL Set ID 592dbfb2-868a-4bfc-bf55-608da46395d4
Route
TOPICAL
Published
Effective Date 2018-06-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Citric Acid Monohydrate Edetate Disodium Glycerin Poloxamer 188 Polysorbate 20 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-11-11

Description

Hydrocortisone 1.0%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1.0%

Uses

For the temporary relief of itching associated with

minor skin irritation and rashes due to: • eczema • poison ivy,

oak and sumac • cosmetics • jewelry • soaps and detergents

• insect bites. Other uses of this product should be only under

the advice and supervision of a doctor.

Section 51945-4

Warnings

​For external use only.

Flammable:Keep away from fire or flame

Avoid contact with the eyes. If condition worsens, or if

symptoms persist for more than 7 days or clear up and occur

again within a few days, stop use of this product and do not

begin use of any other hydrocortisone product unless you have

consulted a doctor. Do not use for the treatment of diaper rash.

Consult a doctor.

Do not puncture or incinerate. Contents under pressure. Do not

store at temperatures above 120˚F

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

Active Ingredient

Hydrocortisone 1.0%

Inactive Ingredients

Citric Acid, Disodium EDTA, Glycerin, Poloxamer 188, Polysorbate 20, SD Alcohol 40-B, Water.

Keep Out of Reach of Children.

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


Structured Label Content

Uses

For the temporary relief of itching associated with

minor skin irritation and rashes due to: • eczema • poison ivy,

oak and sumac • cosmetics • jewelry • soaps and detergents

• insect bites. Other uses of this product should be only under

the advice and supervision of a doctor.

Section 51945-4 (51945-4)

Purpose

Anti-itch

Warnings

​For external use only.

Flammable:Keep away from fire or flame

Avoid contact with the eyes. If condition worsens, or if

symptoms persist for more than 7 days or clear up and occur

again within a few days, stop use of this product and do not

begin use of any other hydrocortisone product unless you have

consulted a doctor. Do not use for the treatment of diaper rash.

Consult a doctor.

Do not puncture or incinerate. Contents under pressure. Do not

store at temperatures above 120˚F

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

Active Ingredient (Active ingredient)

Hydrocortisone 1.0%

Inactive Ingredients

Citric Acid, Disodium EDTA, Glycerin, Poloxamer 188, Polysorbate 20, SD Alcohol 40-B, Water.

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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