Drug Facts 11429-1004

Drug Facts 11429-1004
SPL v6
SPL
SPL Set ID 2e9c752c-ad69-4692-a17a-e98b84c7e9a5
Route
TOPICAL
Published
Effective Date 2025-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Diethanolamine Bis(c8-c18 Perfluoroalkylethyl)phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-03-31 Until 2021-12-31

Description

Active Ingredient Ethyl Alcohol 62% v/v


Medication Information

Warnings and Precautions

Warnings:

Flammable. Keep away from fire or flame

For external use only

Indications and Usage

Uses:

For hand sanitizing to decrease bacteria on the skin that could cause disease.

Recommended for repeated use.

Dosage and Administration

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.

Description

Active Ingredient Ethyl Alcohol 62% v/v

Section 44425-7

Other information:

Store below 110 F (43 C).

May discolor certain fabrics or surfaces.

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 redness develops, or if condition persists for more than 72 hours.

Section 50567-7

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Section 51727-6

Inactive ingredients:

Aqua, DEA-C8-18 Perfluoroalkylethyl Phosphate

Section 51945-4

Alco-Foam

Hand Sanitizer

Decreases common

germs thatcan cause

illness. Leaves skin

soft and refreshed.

NSF

Nonfood Compounds

Program Listed E3

158544

Woodbine Products Company

915 West Smith Road

Medina, Ohio 44256

www.woodbineproducts.com

Made in the USA

Stock # 470G 3.78 Liters (1 Gallon)

Section 55105-1

Purpose

Sanitizer

Section 55106-9

Active Ingredient

Ethyl Alcohol 62% v/v


Structured Label Content

Indications and Usage (34067-9)

Uses:

For hand sanitizing to decrease bacteria on the skin that could cause disease.

Recommended for repeated use.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings:

Flammable. Keep away from fire or flame

For external use only

Section 44425-7 (44425-7)

Other information:

Store below 110 F (43 C).

May discolor certain fabrics or surfaces.

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 redness develops, or if condition persists for more than 72 hours.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Section 51727-6 (51727-6)

Inactive ingredients:

Aqua, DEA-C8-18 Perfluoroalkylethyl Phosphate

Section 51945-4 (51945-4)

Alco-Foam

Hand Sanitizer

Decreases common

germs thatcan cause

illness. Leaves skin

soft and refreshed.

NSF

Nonfood Compounds

Program Listed E3

158544

Woodbine Products Company

915 West Smith Road

Medina, Ohio 44256

www.woodbineproducts.com

Made in the USA

Stock # 470G 3.78 Liters (1 Gallon)

Section 55105-1 (55105-1)

Purpose

Sanitizer

Section 55106-9 (55106-9)

Active Ingredient

Ethyl Alcohol 62% v/v


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)