85279-002

85279-002
SPL v3
SPL
SPL Set ID 2e9db49b-35ce-00d5-e063-6294a90acf35
Route
TRANSDERMAL
Published
Effective Date 2025-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (60 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-21

Description

Ethyl Alcohol 60%.

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 60%.

Use

Use(s) Hand sanitizer 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.

Warnings

Warnings For external use only. Flammable. Keep away from heat or flame.

Directions

●Place enough product on hands to cover all surfaces. Rub hands together until dry.

●Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use

●in children less than 2 months of age

●on open skin wounds

Other Information

●Store below 106°F (41°C)

●May discolor certain fabrics or surfaces

●Validity period after opening: 12 months

Active Ingredient(s)

Ethyl Alcohol 60%.

Inactive Ingredients

Sterile Distilled Water

Package Label Principal Display Panel


Structured Label Content

Use

Use(s) Hand sanitizer 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.

Purpose

Antiseptic

Warnings

Warnings For external use only. Flammable. Keep away from heat or flame.

Directions

●Place enough product on hands to cover all surfaces. Rub hands together until dry.

●Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use (Do not use)

●in children less than 2 months of age

●on open skin wounds

Other Information (Other information)

●Store below 106°F (41°C)

●May discolor certain fabrics or surfaces

●Validity period after opening: 12 months

Active Ingredient(s)

Ethyl Alcohol 60%.

Inactive Ingredients (Inactive ingredients)

Sterile Distilled Water

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)