a9bcecf7-7767-69b4-e053-2995a90a9247

SPL v2
SPL
SPL Set ID a9bcecf7-7767-69b4-e053-2995a90a9247
Route
topical
Published
Effective Date 2020-07-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (75 mL)
Inactive Ingredients
carbomer homopolymer, unspecified type aloe vera leaf trolamine .alpha.-tocopherol glycerin water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-07-06

Purpose

Antiseptic

Description

Ethyl Alcohol 75%


Medication Information

Warnings

For external use only

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

FLAMMABLE, KEEP AWAY FROM FIRE

Uses

To help reduce bacteria on the skin

Purpose

Antiseptic

Directions

Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

Other Information

Store below 110F(43C)

May discolor certain fabrics or surfaces

Inactive Ingredients

Aqua

Glycerin

Carbomer

Aloe Vera

Triethanolamine

Vitamin E

Description

Ethyl Alcohol 75%

Label

Active Ingredient

Ethyl Alcohol 75%

Stop Use and Ask A Doctor

Stop use and ask a doctor if rash or irritation or redness develops and lasts.

Keep Out of Reach of Children

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


Structured Label Content

Warnings

For external use only

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

FLAMMABLE, KEEP AWAY FROM FIRE

Uses

To help reduce bacteria on the skin

Purpose

Antiseptic

Directions

Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

Other Information (Other information)

Store below 110F(43C)

May discolor certain fabrics or surfaces

Inactive Ingredients

Aqua

Glycerin

Carbomer

Aloe Vera

Triethanolamine

Vitamin E

Label (label)

Active Ingredient

Ethyl Alcohol 75%

Stop Use and Ask A Doctor (Stop Use and Ask a Doctor)

Stop use and ask a doctor if rash or irritation or redness develops and lasts.

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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