RxNorm Names

Review RxNorm Normal Forms

OOSAFE (benzalkonium chloride) liquid
[SPARMED ApS]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e563d411-4c37-48ee-91fe-269a8b80aded

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

Active Ingredient

Benzlakonium Chloride 1.3 gram/liter.

Purpose

Disinfectant

Warnings

Harmful to health in case of in appropriate utilisation.Keep out of reach of children.

Inactive Ingredients

Water

Keep Out of Reach of Children

Keep out of reach of children

Dosage and Administration

Apply evenly on the surface wait 15 minutes to dry out for the best results and clean with sterile sponge or cloth impregnated sterile water.

Indication and Usage

Disinfectant -effective against hepatitis B HIV Rota virus with in 1 minute, mycobacterium with in 5 minute, and bacteria fungi (candida), influenza A virus (H5N1/H1N1) with in 15 minutes.

Package Label Principal Display Panel

OOSAFE
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52759-922
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM)	BENZALKONIUM CHLORIDE	1.3 g in 1 L

Inactive Ingredients
Ingredient Name	Strength
Water

Packaging
#	Item Code	Package Description
1	NDC:52759-922-01	1 L in 1 BOTTLE
2	NDC:52759-922-05	5 L in 1 BOTTLE
3	NDC:52759-922-10	10 L in 1 BOTTLE
4	NDC:52759-922-00	0.250 L in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/30/2012

Labeler - SPARMED ApS (311811306)

Revised: 09/2012

Document Id: 03f8b1ac-56c8-4234-bc83-d360ba1596d3

Set id: e563d411-4c37-48ee-91fe-269a8b80aded

Version: 2

Effective Time: 20120930

SPARMED ApS

Daily Med

Current Medication Information

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