Drug Facts 11429-1002

Drug Facts 11429-1002
SPL v5
SPL
SPL Set ID c49f49ad-06fc-4759-9ac9-1f1e29d8c2cf
Route
TOPICAL
Published
Effective Date 2014-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Coco Glucoside Laurtrimonium Chloride Cocamidopropylamine Oxide Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-02-26

Description

Active Ingredient Benzalkonium Chloride 0.13%


Medication Information

Warnings and Precautions

Warnings:

For external use only

Indications and Usage

Uses:

For hand washing to decrease bacteria on the skin.

Recommended for repeated use.

Dosage and Administration

Directions:

Pump a small amount of foam into palm of hand.

Rub thoroughly over all surfaces of both hands for 15 seconds.

Rinse with potable water.

Description

Active Ingredient Benzalkonium Chloride 0.13%

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 with water.

Section 51727-6

Inactive Ingredients:

Water, Coco-Glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric Acid.

Section 51945-4

FoamFresh

E-2 Sanitizer Cleanser

For Food Service and Health Care

For Food Service:

A "one-step" E-2 hand wash to effectively reduce bacteria flora on the skin without need for a prewash.

Contains no perfume, dyes or contaminants to affect food products.

For Health Care:

Mild yet effective hand wash for high risk areas.

Dye and fragrance free formula for frequent hand washings.

Excellent skin compatibility.

Woodbine Products Company

915 West Smith Road

Medina, OH 44256

www.woodbineproducts.com

Made in USA

Stock # 4560                 1000 ml (34 fl. oz.)

FoamFresh E-2 Sanitizer

With Moisturizers

Section 55105-1

Purpose

Antimicrobial

Section 55106-9

Active Ingredient

Benzalkonium Chloride 0.13%


Structured Label Content

Indications and Usage (34067-9)

Uses:

For hand washing to decrease bacteria on the skin.

Recommended for repeated use.

Dosage and Administration (34068-7)

Directions:

Pump a small amount of foam into palm of hand.

Rub thoroughly over all surfaces of both hands for 15 seconds.

Rinse with potable water.

Warnings and Precautions (34071-1)

Warnings:

For external use only

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 with water.

Section 51727-6 (51727-6)

Inactive Ingredients:

Water, Coco-Glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric Acid.

Section 51945-4 (51945-4)

FoamFresh

E-2 Sanitizer Cleanser

For Food Service and Health Care

For Food Service:

A "one-step" E-2 hand wash to effectively reduce bacteria flora on the skin without need for a prewash.

Contains no perfume, dyes or contaminants to affect food products.

For Health Care:

Mild yet effective hand wash for high risk areas.

Dye and fragrance free formula for frequent hand washings.

Excellent skin compatibility.

Woodbine Products Company

915 West Smith Road

Medina, OH 44256

www.woodbineproducts.com

Made in USA

Stock # 4560                 1000 ml (34 fl. oz.)

FoamFresh E-2 Sanitizer

With Moisturizers

Section 55105-1 (55105-1)

Purpose

Antimicrobial

Section 55106-9 (55106-9)

Active Ingredient

Benzalkonium Chloride 0.13%


Advanced Ingredient Data


Raw Label Data

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