Label: HAND SANITIZER- benzalkonium chloride liquid
HAND SANITIZER- benzalkonium chloride spray
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Contains inactivated NDC Code(s)
NDC Code(s): 78522-100-00, 78522-104-00 - Packager: Northmed SIA
- 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 October 26, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STORAGE AND HANDLING
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HAND SANITIZER
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78522-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 2 mg in 59 mL Inactive Ingredients Ingredient Name Strength TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) ALOE VERA LEAF (UNII: ZY81Z83H0X) PANTHENOL (UNII: WV9CM0O67Z) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78522-104-00 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/27/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/27/2021 HAND SANITIZER
benzalkonium chloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78522-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 2 mg in 59 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) PANTHENOL (UNII: WV9CM0O67Z) GLYCERIN (UNII: PDC6A3C0OX) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78522-100-00 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/05/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/05/2021 Labeler - Northmed SIA (662588132) Establishment Name Address ID/FEI Business Operations Northmed SIA 662588132 manufacture(78522-100, 78522-104) , pack(78522-104) , label(78522-104)
