Cooling Itch Relief Spray

Cooling Itch Relief Spray
SPL v7
SPL
SPL Set ID a24bdea0-18e8-8a5e-e053-2995a90acea2
Route
TOPICAL
Published
Effective Date 2018-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-08

Description

Hydrocortisone 1% Anti itch Principal Display Panel Anti Itch Spray.jpg

Dosage and Administration

See Attached Image File Principal Display Panel Anti Itch Spray


Medication Information

Dosage and Administration

See Attached Image File Principal Display Panel Anti Itch Spray

Description

Hydrocortisone 1% Anti itch Principal Display Panel Anti Itch Spray.jpg

Uses

Temporarily relieves itching associated with minorskin irritation and rashes due to:• eczema • poison ivy, oak and sumac • cosmetics• psoriasis • soaps and detergents • jewelry• insect bites • seborrheic dermatitis

Warnings

For external use only

Do Not Use

• in or near the eyes • for external genital • vaginal or anal itching • for diaper rash: ask a doctor

Anti Itch Spray

Indication & Usage

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.

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

Inactive Ingredient

Citric Acid, Disodium EDTA, Glycerin, Poloxamer 407, Polysorbate 20, SD Alcohol 40-B, Water

When Using This Product

• Keep out of eyes. Rinse with water to remove • Use only as directed. • Do not puncture or incinerate. Contents under pressure• Do not store at temperature above 120F

Stop Use and Ask A Doctor If

• condition worsens or does not improve withing 7 days• symptomspersist more than 7 days or clear up and occur again within a few days

Otc Active Ingredient Section

Hydrocortisone 1% Anti itch

Principal Display Panel Anti Itch Spray.jpg

Keep Out of Reach of the Children

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

Otc Keep Out of Reach of Children

Keep out of reach of the children

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


Structured Label Content

Uses (USES)

Temporarily relieves itching associated with minorskin irritation and rashes due to:• eczema • poison ivy, oak and sumac • cosmetics• psoriasis • soaps and detergents • jewelry• insect bites • seborrheic dermatitis

Warnings (WARNINGS)

For external use only

Do Not Use (DO NOT USE)

• in or near the eyes • for external genital • vaginal or anal itching • for diaper rash: ask a doctor

Anti Itch Spray (Anti-Itch Spray)

Indication & Usage

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.

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

Inactive Ingredient (INACTIVE INGREDIENT)

Citric Acid, Disodium EDTA, Glycerin, Poloxamer 407, Polysorbate 20, SD Alcohol 40-B, Water

When Using This Product (WHEN USING THIS PRODUCT)

• Keep out of eyes. Rinse with water to remove • Use only as directed. • Do not puncture or incinerate. Contents under pressure• Do not store at temperature above 120F

Dosage and Administration

See Attached Image File Principal Display Panel Anti Itch Spray

Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

• condition worsens or does not improve withing 7 days• symptomspersist more than 7 days or clear up and occur again within a few days

Otc Active Ingredient Section (OTC Active Ingredient Section)

Hydrocortisone 1% Anti itch

Principal Display Panel Anti Itch Spray.jpg

Keep Out of Reach of the Children (KEEP OUT OF REACH OF THE CHILDREN)

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

Otc Keep Out of Reach of Children (OTC - Keep Out of Reach of Children)

Keep out of reach of the children

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


Advanced Ingredient Data


Raw Label Data

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