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

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


Medication Information

Warnings

For external use only

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

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

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

Warnings (WARNINGS)

For external use only

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

Dosage and Administration

See Attached Image File Principal Display Panel Anti Itch Spray

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

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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