Drug Facts 11429-1001

Drug Facts 11429-1001
SPL v5
SPL
SPL Set ID 59614a1a-6b76-45e7-8b57-af307a1673cf
Route
TOPICAL
Published
Effective Date 2014-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1 mg)
Inactive Ingredients
Water Cetrimonium Chloride Laurtrimonium Chloride Dihydroxyethyl Cocamine Oxide Glycereth-17 Cocoate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-04-16 Until 2021-12-31

Description

Active Ingredient Benzalkonium Chloride 0.1%


Medication Information

Warnings and Precautions

Warnings:

For external use only

Indications and Usage

Uses:

For hand sanitizing 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.

Rub hands together briskly until dry.

Description

Active Ingredient Benzalkonium Chloride 0.1%

Section 50565-1

Keep out of reach of children.

Children must be supervised in use of this product.

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 conditions 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:

Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid, Fragrance.

Section 51945-4

FoamFresh

Alco-Free Hand Sanitizer

Formulated to reduce the number of germs on the hands that can cause infection and illness

Alcohol free, so it can be used in any area without fear of it creating a flammable atmosphere

Use on clean, non-soiled hands any time when rinsing with water is not available

Kills 99.99% of common germs that can cause disease

PK

Woodbine Products Company

915 West Smith Road

Medina, Ohio 44256

wwww.woodbineproducts.com

Made in the U.S.A.

Stock # 4350         1000 ml (34 fl. oz.)

Section 55105-1

Purpose

Antimicrobial

Section 55106-9

Active Ingredient

Benzalkonium Chloride 0.1%


Structured Label Content

Indications and Usage (34067-9)

Uses:

For hand sanitizing 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.

Rub hands together briskly until dry.

Warnings and Precautions (34071-1)

Warnings:

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

Children must be supervised in use of this product.

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 conditions 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:

Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid, Fragrance.

Section 51945-4 (51945-4)

FoamFresh

Alco-Free Hand Sanitizer

Formulated to reduce the number of germs on the hands that can cause infection and illness

Alcohol free, so it can be used in any area without fear of it creating a flammable atmosphere

Use on clean, non-soiled hands any time when rinsing with water is not available

Kills 99.99% of common germs that can cause disease

PK

Woodbine Products Company

915 West Smith Road

Medina, Ohio 44256

wwww.woodbineproducts.com

Made in the U.S.A.

Stock # 4350         1000 ml (34 fl. oz.)

Section 55105-1 (55105-1)

Purpose

Antimicrobial

Section 55106-9 (55106-9)

Active Ingredient

Benzalkonium Chloride 0.1%


Advanced Ingredient Data


Raw Label Data

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