OOSAFE DISINFECTANT- 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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Oosafe Disinfectant

Purpose

Purpose

Application

Application

Dosage Administration

Dosage Administration

Active Ingredients

Active Ingredients

Inactive Ingredients

Inactive Ingredients

Warning

Warning

Keep Out of Reach

Keep Out of Reach

Oosafe 250 ml label

Display 250 ml

OOSAFE  DISINFECTANT
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) 991 g  in 1 L
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 3.7 g  in 1 L
SODIUM NITRITE (UNII: M0KG633D4F) 4 g  in 1 L
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52759-922-01 1 L in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2012
2 NDC:52759-922-05 5 L in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2012
3 NDC:52759-922-10 10 L in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2012
4 NDC:52759-922-00 0.25 L in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2012
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: 4/2017
Document Id: 4d86055e-741c-4d06-e054-00144ff88e88
Set id: e563d411-4c37-48ee-91fe-269a8b80aded
Version: 3
Effective Time: 20170419
 
SparMED ApS