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

Application

Dosage Administration

Active Ingredients

Inactive Ingredients

Warning

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 g in 1 L

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	991 g in 1 L
SODIUM NITRITE (UNII: M0KG633D4F)	4 g in 1 L
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	3.7 g in 1 L

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52759-922-01	1 L in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2012	11/30/2020
2	NDC:52759-922-05	5 L in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2012	11/30/2020
3	NDC:52759-922-10	10 L in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2012	11/30/2020
4	NDC:52759-922-00	0.25 L in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2012	11/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/30/2012	11/30/2020

Labeler - SparMED ApS (311811306)

Revised: 1/2019

Document Id: 7ee12d07-3587-ff1f-e053-2a91aa0a8f31

Set id: e563d411-4c37-48ee-91fe-269a8b80aded

Version: 4

Effective Time: 20190107

SparMED ApS