Label: OOSAFE - benzalkonium chloride liquid
- NDC Code(s): 52759-922-00, 52759-922-01, 52759-922-05, 52759-922-10
- Packager: SPARMED ApS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated September 30, 2012
If you are a consumer or patient please visit this version.
- Active Ingredient
Benzlakonium Chloride 1.3 gram/liter.
Harmful to health in case of in appropriate utilisation.Keep out of reach of children.Close
- Inactive Ingredients
- Keep Out of Reach of Children
Keep out of reach of childrenClose
- 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.Close
- 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.Close
- Package Label Principal Display Panel
- INGREDIENTS AND APPEARANCE
benzalkonium chloride liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52759-922 Route of Administration TOPICAL 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)