Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 463a7d7f-9a1a-4434-b48d-efe331be26a6
Route
TOPICAL
Published
Effective Date 2011-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.001 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-10-05

Description

ACTIVE INGREDIENT:   Benzalkonium Chloride, 0.133% w/v


Medication Information

Warnings and Precautions

DO NOT USE: In the eyes or apply over large areas of the body.

STOP USE: If irritation, redness or other symptoms develop.  Consult a doctor if the condition persists or gets worse.

Indications and Usage

USE:  Antiseptic Cleansing of face, hands and body without soap and water. Air dries in seconds.

Dosage and Administration

Contains 1 Pad

DIRECTIONS: Tear open packet, unfold and use as washcloth

Description

ACTIVE INGREDIENT:   Benzalkonium Chloride, 0.133% w/v

Section 50565-1

Caution Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

INACTIVE INGREDIENT: Distilled Water

Section 55105-1

PURPOSE:

First Aid Antiseptic

Section 55106-9

ACTIVE INGREDIENT:

 Benzalkonium Chloride, 0.133% w/v





Principal Display Panel Pouch Label

HENRY SCHEIN®

112-5824

NDC 0404-5824-01

BZK

TOWELETTE

Contains Benzalkonium Chloride

For External Use Only


NON-STERILE

Contains

1 Pad

CE

Distributed by:

HENRY SCHEIN INC.

Melville, NY 11747 USA

EC REP

Henry Schein U.K. Holdings Ltd.

Gillingham ME8 0SB U.K.


Structured Label Content

Indications and Usage (34067-9)

USE:  Antiseptic Cleansing of face, hands and body without soap and water. Air dries in seconds.

Dosage and Administration (34068-7)

Contains 1 Pad

DIRECTIONS: Tear open packet, unfold and use as washcloth

Warnings and Precautions (34071-1)

DO NOT USE: In the eyes or apply over large areas of the body.

STOP USE: If irritation, redness or other symptoms develop.  Consult a doctor if the condition persists or gets worse.

Section 50565-1 (50565-1)

Caution Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

INACTIVE INGREDIENT: Distilled Water

Section 55105-1 (55105-1)

PURPOSE:

First Aid Antiseptic

Section 55106-9 (55106-9)

ACTIVE INGREDIENT:

 Benzalkonium Chloride, 0.133% w/v





Principal Display Panel Pouch Label (PRINCIPAL DISPLAY PANEL - Pouch Label)

HENRY SCHEIN®

112-5824

NDC 0404-5824-01

BZK

TOWELETTE

Contains Benzalkonium Chloride

For External Use Only


NON-STERILE

Contains

1 Pad

CE

Distributed by:

HENRY SCHEIN INC.

Melville, NY 11747 USA

EC REP

Henry Schein U.K. Holdings Ltd.

Gillingham ME8 0SB U.K.


Advanced Ingredient Data


Raw Label Data

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