Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 1b45f435-dbcf-4560-a189-72c7ef48cfd9
Route
TOPICAL
Published
Effective Date 2013-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Cetrimonium Chloride Laurtrimonium Chloride Glycereth-17 Cocoate Dihydroxyethyl Cocamine Oxide Polihexanide C12-15 Pareth-7 Citric Acid Monohydrate Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-03-08

Description

Active ingredient Benzalkonium Chloride 0.13%


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 onto hands



Rub thoroughly over all surfaces of both hands



Rub hands together briskly until dry





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 eyes with water.

Section 51727-6

Inactive ingredients

Water, Cetrimonium Chloride, Laurtrimonium Chloride, Glycereth-17 Cocoate, Dihydroxyethyl Cocamine Oxide, Polyaminopropyl Biguanide, C8-10-Alkyl Polyglucoside, C12-15 Pareth-7, Citric Acid, Dimethicone

Section 51945-4

100%

Hygeine

Revolution

Byotrol

Alcohol Free

Kills Germs

Antibacterial Foaming

Hand Sanitizer

Powerful

No other FDA compliant hand antiseptic claims more.

Long Lasting

Foaming formula lasts, increasing wet contact time, to deliver the persistent performance Byotrol is known for.

Gentle

Alcohol Free Formula is hard on germs and soft on hands.

byotrol

Net Contents: 42.26 fl.Oz. (1,250ml)



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 sanitizing to decrease bacteria on the skin

Recommended for repeated use

Dosage and Administration (34068-7)


Directions



Pump a small amount of foam onto hands



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.

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

Water, Cetrimonium Chloride, Laurtrimonium Chloride, Glycereth-17 Cocoate, Dihydroxyethyl Cocamine Oxide, Polyaminopropyl Biguanide, C8-10-Alkyl Polyglucoside, C12-15 Pareth-7, Citric Acid, Dimethicone

Section 51945-4 (51945-4)

100%

Hygeine

Revolution

Byotrol

Alcohol Free

Kills Germs

Antibacterial Foaming

Hand Sanitizer

Powerful

No other FDA compliant hand antiseptic claims more.

Long Lasting

Foaming formula lasts, increasing wet contact time, to deliver the persistent performance Byotrol is known for.

Gentle

Alcohol Free Formula is hard on germs and soft on hands.

byotrol

Net Contents: 42.26 fl.Oz. (1,250ml)



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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