Label: HAND SANITISER FOAM- benzalonium chloride liquid
SANITIZINGSOAP- benzalonium chloride liquid
HAND SANITIZER GEL- benzalonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 51706-806-01, 51706-806-02, 51706-806-03, 51706-807-01, view more51706-807-02, 51706-807-03, 51706-808-01, 51706-808-02 - Packager: Landy International
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 6, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HAND SANITISER FOAM
benzalonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51706-807 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:51706-807-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2020 2 NDC:51706-807-02 244 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2020 3 NDC:51706-807-03 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 not final part333E 06/01/2020 SANITIZINGSOAP
benzalonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51706-806 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:51706-806-01 1200 mL in 1 BAG; Type 0: Not a Combination Product 06/01/2020 2 NDC:51706-806-02 244 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2020 3 NDC:51706-806-03 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 not final part333E 06/01/2020 HAND SANITIZER GEL
benzalonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51706-808 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:51706-808-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2020 2 NDC:51706-808-02 90 mL in 1 BOX; 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 not final part333E 06/01/2020 Labeler - Landy International (545291775) Establishment Name Address ID/FEI Business Operations Landy International 545291775 manufacture(51706-806, 51706-807, 51706-808)
