RxNorm Names

Not yet provided

HAND SANITIZER (benzalkonium chloride) liquid
[Henry Schein, Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f515a055-285a-46dc-8649-0fd2c2930e05

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not final

NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.39%

Purpose

Antiseptic

Uses

for handwashing to decrease bacteria on skin without soap and water
recommended for repeated use

Warnings

For external use only. Flammable, keep away from fire or flame

Do not use in the eyes. If this happens, rinse thoroughly with water

Stop use and ask doctor if irritation and redness develop and persists for more than 72 hours

Keep out of reach of children

If ingested get medical help or contact a Poison Control Center right away

Directions

wet hands thoroughly with product
allow to dry without wiping
children under 6 should be supervised while using this product

Inactive Ingredients

aloe vera, propylene glycol, fragrance, purified water, germaben II, ganex p-904 LC

Distributed by:

Distribuido por: Distribuépar:
HENRY SCHEIN, Inc.

135 Duryea Road
Melville, NY 11747 USA

Made in U.S.A.

PRINCIPAL DISPLAY PANEL – 50 mL Bottle Label

Henry Schein

Hand Sanitizer

Mountain Meadow

Jabón higiénico
de manos

Désinfectant pour
les mains

Foaming

Alcohol Free

2 fl. oz. (50 ml)

PRINCIPAL DISPLAY PANEL – 50 mL Bottle Label

HAND SANITIZER
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0404-4445
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
benzalkonium chloride (benzalkonium)	benzalkonium chloride	7.49 g in 1 L

Inactive Ingredients
Ingredient Name	Strength
water
aloe vera leaf
propylene glycol
diazolidinyl urea

Packaging
#	Item Code	Package Description
1	NDC:0404-4445-01	0.05 L in 1 BOTTLE, PUMP
2	NDC:0404-4445-02	0.55 L in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/30/2013

Labeler - Henry Schein, Inc. (012430880)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(0404-4445)

Revised: 01/2013

Document Id: 060de390-968b-4cc1-8206-e5d952711d9a

Set id: f515a055-285a-46dc-8649-0fd2c2930e05

Version: 1

Effective Time: 20130130

Henry Schein, Inc.

Daily Med

Current Medication Information

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