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

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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Purified water，Benzalkonium Chloride，TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE， Polyaminopropyl biguanide hcl

Benzalkonium Chloride 0.13%

Benzalkonium Chloride 0.1%

NDC 51706-806 806 package

51706-807 NDC 807 package

51706-808 NDC 808

HAND SANITISER FOAM 
benzalonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-807
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 96.59 mL  in 100 mL
POLIHEXANIDE (UNII: 322U039GMF) 0.26 mL  in 100 mL
TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B) 0.74952 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51706-807-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
2NDC:51706-807-02244 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
3NDC:51706-807-031200 mL in 1 BAG; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/2020
SANITIZINGSOAP 
benzalonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-806
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE10 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 80.6 mL  in 100 mL
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233) 12 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
BENZYL ALCOHOL (UNII: LKG8494WBH) 1 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51706-806-011200 mL in 1 BAG; Type 0: Not a Combination Product06/01/2020
2NDC:51706-806-02244 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
3NDC:51706-806-033780 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/2020
HAND SANITIZER GEL 
benzalonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-808
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 96.59 mL  in 100 mL
POLIHEXANIDE (UNII: 322U039GMF) 0.26 mL  in 100 mL
TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B) 0.74952 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51706-808-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
2NDC:51706-808-0290 mL in 1 BOX; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/2020
Labeler - Landy International (545291775)
Establishment
NameAddressID/FEIBusiness Operations
Landy International545291775manufacture(51706-806, 51706-807, 51706-808)

Revised: 6/2020
Document Id: a76b1715-01a1-6ea6-e053-2995a90a9d29
Set id: a768f84a-25c8-5d04-e053-2a95a90a5570
Version: 1
Effective Time: 20200606
 
Landy International