OOSAFE - benzalkonium chloride liquid 
SPARMED ApS

Disclaimer: 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.

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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



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OOSAFE 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52759-922
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE1.3 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
Water 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52759-922-011 L in 1 BOTTLE
2NDC:52759-922-055 L in 1 BOTTLE
3NDC:52759-922-1010 L in 1 BOTTLE
4NDC:52759-922-000.250 L in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/30/2012
Labeler - SPARMED ApS (311811306)

Revised: 9/2012
Document Id: 03f8b1ac-56c8-4234-bc83-d360ba1596d3
Set id: e563d411-4c37-48ee-91fe-269a8b80aded
Version: 2
Effective Time: 20120930
 
SPARMED ApS