79864-002

79864-002
SPL v2
SPL
SPL Set ID ac926138-12f9-5d34-e053-2995a90a8ee0
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
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

Ethyl Alcohol 75%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75%

Use

Sanitizing spray to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry. Children under 6 years of age should be supervised when using this product.

Do Not Use

Do not use in children less than 2 months of age, nor on open skin wounds.

Other Information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

May discolor certain fabrics or surfaces

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients

Purified Water

Package Label Principal Display Panel


Structured Label Content

Use

Sanitizing spray to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antiseptic

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry. Children under 6 years of age should be supervised when using this product.

Do Not Use (Do not use)

Do not use in children less than 2 months of age, nor on open skin wounds.

Other Information (Other information)

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

May discolor certain fabrics or surfaces

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients (Inactive ingredients)

Purified Water

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)