55028-015

55028-015
SPL v2
SPL
SPL Set ID b62b87bd-6d02-38bd-e053-2a95a90a397f
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Glycerin Carbomer Homopolymer, Unspecified Type Water Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-30

Description

Ethyl Alcohol 75% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75% v/v

Use

Hand sanitizer to help decrease bacteria on the surface of skin.

Section 50565-1

Keep out of reach of children

Children must be supervised in use of this product.

Section 50566-9

Stop use and ask a doctor if

Irritation or redness develops and lasts.

Section 50567-7

When using this product

Avoid contact with eyes.

If contact occurs, rinse thoroughly with water.

Warnings

Flammable, Keep away from source of heat,fire or flame.

For external use only.

Do not apply around the eyes.

Do not use in ears & mouth.

Directions

Pump enough product into your plams and thoroughly spread on both hands, rub into skin until dry. Children under 6 years should be supervised when using this product.

Do Not Use

Do not apply around the eyes.

Do not use in ears & mouth.

Other Information

Store at temperature below 43°C (110°F)

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Inactive Ingredients

Water, triethanolamine, glycerin, carbomer

Package Label Principal Display Panel


Structured Label Content

Use

Hand sanitizer to help decrease bacteria on the surface of skin.

Section 50565-1 (50565-1)

Keep out of reach of children

Children must be supervised in use of this product.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

Irritation or redness develops and lasts.

Section 50567-7 (50567-7)

When using this product

Avoid contact with eyes.

If contact occurs, rinse thoroughly with water.

Purpose

Antiseptic

Warnings

Flammable, Keep away from source of heat,fire or flame.

For external use only.

Do not apply around the eyes.

Do not use in ears & mouth.

Directions

Pump enough product into your plams and thoroughly spread on both hands, rub into skin until dry. Children under 6 years should be supervised when using this product.

Do Not Use (Do not use)

Do not apply around the eyes.

Do not use in ears & mouth.

Other Information (Other information)

Store at temperature below 43°C (110°F)

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Inactive Ingredients (Inactive ingredients)

Water, triethanolamine, glycerin, carbomer

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)