cortizone 10 cooling spray

cortizone 10 cooling spray
SPL v1
SPL
SPL Set ID 01cd77e3-380f-4487-ae6e-3ac45355d8a4
Route
topical
Published
Effective Date 2025-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrocortisone (1 g)
Inactive Ingredients
alcohol aloe vera leaf oat citric acid monohydrate diethylene glycol monoethyl ether glycerin hydroxypropyl cellulose, unspecified isobutane menthyl lactate, (-)- methyl gluceth-20 polyethylene glycol 400 water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-01-03

Purpose

Anti-Itch 

Description

Drug Facts


Medication Information

Warnings

For external use only .

Flam mable. Keep away from fire or flame.  

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

       eczema  psoriasis    poison ivy, oak, sumac  insect bites  detergents  jewelry    cosmetics

        soaps  seborrheic dermatitis

 other uses of this product should be only under the advice and supervision of a doctor

Purpose

Anti-Itch 

Other Information

Store between 20° to 25°C (68° to 77°F)

Description

Drug Facts

Principal Display Panel

Cortizone 10

FAST ACTING

ITCH RELIEF

COOLING SPRAY

SOOTHING ALOE

1% Hydrocortisone

Anti-Itch Spray

Net wt 2.7 oz (76 g)

D

adults and children 2 years of age and older: apply to affected area. Do not use more than 3 to 4 times daily.

  children under 2 years of age: do not use, ask a doctor.

Section 42229-5

Drug Facts

Inactive

alcohol denat., aloe barbadensis leaf juice, avena sativa (oat) kernel extract, citric acid, ethoxydiglycol, glycerin, hydroxypropyl cellulose, isobutane, menthyl lactate, methyl gluceth-20, PEG-8, water

Do Not Us

■ for the treatment of diaper rash. Consult a doctor. 

■ if you are allergic to any ingredient in this product.

Active Ingredients

Hydrocortisone 1%

When Using This Product

 avoid contact with the eyes 

■ contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120° F. 

■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

■ do not use more than directed unless told to do so by a doctor

Stop Use and Ask A Doctor If

condition worsens

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

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 .

Flam mable. Keep away from fire or flame.  

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

       eczema  psoriasis    poison ivy, oak, sumac  insect bites  detergents  jewelry    cosmetics

        soaps  seborrheic dermatitis

 other uses of this product should be only under the advice and supervision of a doctor

Purpose

Anti-Itch 

Other Information (Other information)

Store between 20° to 25°C (68° to 77°F)

Principal Display Panel

Cortizone 10

FAST ACTING

ITCH RELIEF

COOLING SPRAY

SOOTHING ALOE

1% Hydrocortisone

Anti-Itch Spray

Net wt 2.7 oz (76 g)

D

adults and children 2 years of age and older: apply to affected area. Do not use more than 3 to 4 times daily.

  children under 2 years of age: do not use, ask a doctor.

Section 42229-5 (42229-5)

Drug Facts

Inactive

alcohol denat., aloe barbadensis leaf juice, avena sativa (oat) kernel extract, citric acid, ethoxydiglycol, glycerin, hydroxypropyl cellulose, isobutane, menthyl lactate, methyl gluceth-20, PEG-8, water

Do Not Us (Do not us)

■ for the treatment of diaper rash. Consult a doctor. 

■ if you are allergic to any ingredient in this product.

Active Ingredients (Active ingredients)

Hydrocortisone 1%

When Using This Product (When using this product)

 avoid contact with the eyes 

■ contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120° F. 

■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

■ do not use more than directed unless told to do so by a doctor

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

condition worsens

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

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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