Label: NORTHMED HAND SANITIZER- benzalkonium chloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78522-010-01, 78522-010-02, 78522-010-03, 78522-010-04, view more78522-010-05 - 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 July 22, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
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Warnings
For external use only.
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
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
NORTHMED HAND SANITIZER
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78522-010 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 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PANTHENOL (UNII: WV9CM0O67Z) HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) LINALOOL, (+/-)- (UNII: D81QY6I88E) .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78522-010-01 24 in 1 PACKAGE 07/22/2020 1 2 mL in 1 POUCH; Type 0: Not a Combination Product 2 NDC:78522-010-02 50 mL in 1 TUBE; Type 0: Not a Combination Product 07/22/2020 3 NDC:78522-010-03 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/22/2020 4 NDC:78522-010-04 1000 mL in 1 BAG; Type 0: Not a Combination Product 07/22/2020 5 NDC:78522-010-05 4000 mL in 1 BAG; Type 0: Not a Combination Product 07/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/22/2020 Labeler - Northmed SIA (662588132) Establishment Name Address ID/FEI Business Operations Northmed SIA 662588132 manufacture(78522-010)