Oosafe

Dosage form: liquid
Ingredients: BENZALKONIUM CHLORIDE 1.3g in 1L
Labeler: SPARMED ApS
NDC Code: 52759-922

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.

Active Ingredient    Benzlakonium Chloride 1.3 gram/liter.

PurposeDisinfectant

Warnings

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

Inactive IngredientsWater

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 TypeHUMAN OTC DRUGItem 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 Description
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: 09/2012
 
SPARMED ApS

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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