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 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 (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 g  in 1 L
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
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: 9/2012
Document Id: 03f8b1ac-56c8-4234-bc83-d360ba1596d3
Set id: e563d411-4c37-48ee-91fe-269a8b80aded
Version: 2
Effective Time: 20120930
 
SPARMED ApS