SanitizingSoap by Landy International

SanitizingSoap by

Drug Labeling and Warnings

SanitizingSoap by is a Otc medication manufactured, distributed, or labeled by Landy International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER GEL- benzalonium chloride liquid 
HAND SANITIZER FOAM- benzalonium chloride liquid 
SANITIZINGSOAP- benzalonium chloride liquid 
Landy International

----------

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

51706-804

51706-805

HAND SANITIZER GEL 
benzalonium chloride liquid

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	06/01/2020	08/14/2020

HAND SANITIZER FOAM 
benzalonium chloride liquid

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	06/01/2020	08/14/2020

SANITIZINGSOAP 
benzalonium chloride liquid

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	06/01/2020	08/14/2020

Labeler - Landy International (545291775)

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

Revised: 6/2024

Document Id: 1aadc4ad-1b1f-bdeb-e063-6294a90a81b2

34390-5

Set id: a77bef80-3bc9-41af-e053-2995a90aa12c

Version: 2

Effective Time: 20240612