SPL v5
SPL
SPL Set ID a18a55f5-b3e8-56bc-e053-2a95a90ac2cd
Route
TOPICAL
Published
Effective Date 2020-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (4.17 mL)
Inactive Ingredients
Hydrogen Peroxide Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-24

Description

Alcohol 80%v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 80%v/v

Usage

Hand sanitizer to help reduce bacteria that can cause disease. For use when soap and water are not available

Section 51945-4

Active Ingredients purpose

Alcohol 80%v/v...........................................................................antiseptic

Uses

Hand sanitizer to help reduce bacteria that can cause disease. For use when soap and water are not available

Warnings

For external use only. Flamable. Keep away from heat or flame

Do not use

In children less than two years of age

on open skin wounds

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 doctor if irritation or rash occurs

Keep out of reach of children.

If swallowed get medical help or contact a poison control center immediately

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

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

Other information

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

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

Inactive ingredients, glycerin, hydrogen peroxide, purified water USP

Stop Use

Stop use and ask doctor if irritation or rash occurs

Warnings

For external use only. Flamable. Keep away from heat or flame

Do Not Use

In children less than two years of age or on open skin wounds

Other Information

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

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

Active Ingredients

Alcohol 80%v/v

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Instructions for Use

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

Dosage & Administration

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

Keep Out of Reach of Children

Keep out of reach of children.

If swallowed get medical help or contact a poison control center immediately


Structured Label Content

Usage

Hand sanitizer to help reduce bacteria that can cause disease. For use when soap and water are not available

Section 51945-4 (51945-4)

Active Ingredients purpose

Alcohol 80%v/v...........................................................................antiseptic

Uses

Hand sanitizer to help reduce bacteria that can cause disease. For use when soap and water are not available

Warnings

For external use only. Flamable. Keep away from heat or flame

Do not use

In children less than two years of age

on open skin wounds

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 doctor if irritation or rash occurs

Keep out of reach of children.

If swallowed get medical help or contact a poison control center immediately

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

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

Other information

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

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

Inactive ingredients, glycerin, hydrogen peroxide, purified water USP

Purpose

Antiseptic

Stop Use

Stop use and ask doctor if irritation or rash occurs

Warnings

For external use only. Flamable. Keep away from heat or flame

Do Not Use

In children less than two years of age or on open skin wounds

Other Information (Other information)

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

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

Active Ingredients

Alcohol 80%v/v

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Instructions for Use (Instructions for use)

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

Dosage & Administration

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

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

Keep out of reach of children.

If swallowed get medical help or contact a poison control center immediately


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)