Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 09edbc17-c443-4b0d-9c28-c4b8233c4d1a
Route
TOPICAL
Published
Effective Date 2016-11-07
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 Caprylyl Glucoside C12-15 Pareth-7 Citric Acid Monohydrate Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-05-02

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

Section 51945-4

byotrol

ANTIBACTERIAL FOAMING

HAND SANITIZER

ALCOHOL FREE  KILLS GERMS

POWERFUL

LONG LASTING

GENTLE

Net Contents: 16.9 FL OZ (500mL)

Section 53413-1

Questions? 1-866-443-4509

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

Section 51945-4 (51945-4)

byotrol

ANTIBACTERIAL FOAMING

HAND SANITIZER

ALCOHOL FREE  KILLS GERMS

POWERFUL

LONG LASTING

GENTLE

Net Contents: 16.9 FL OZ (500mL)

Section 53413-1 (53413-1)

Questions? 1-866-443-4509

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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