Active Ingredient(s)

Benzalkonium Chloride 0.13% v/v. Purpose: Antiseptic

Benzalkonium Chloride 0.1%

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

in children less than 2 months of age
on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, Benyzl alcohol, purified water USP, Etc.

Package Label - Principal Display Panel

NDC: 51706-803 803 package

51706-804 804 package

51706-805 805 package

HAND SANITIZER GEL
benzalonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51706-805
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	13 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B)	0.74952 mL in 100 mL
POLIHEXANIDE (UNII: 322U039GMF)	0.26 mL in 100 mL
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51706-805-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
2	NDC:51706-805-02	244 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/01/2020

HAND SANITIZER FOAM
benzalonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51706-804
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	13 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B)	0.74952 mL in 100 mL
POLIHEXANIDE (UNII: 322U039GMF)	0.26 mL in 100 mL
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51706-804-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
2	NDC:51706-804-02	244 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
3	NDC:51706-804-03	1200 mL in 1 BAG; Type 0: Not a Combination Product	06/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/01/2020

SANITIZINGSOAP
benzalonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51706-803
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	10 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL in 100 mL
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)	12 mL in 100 mL
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51706-803-01	1200 mL in 1 BAG; Type 0: Not a Combination Product	06/01/2020
2	NDC:51706-803-02	244 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
3	NDC:51706-803-03	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/01/2020

Labeler - Landy International (545291775)

Name	Address	ID/FEI	Business Operations
Establishment
Landy International		545291775	manufacture(51706-803, 51706-804, 51706-805)