HAND SANITIZER- benzethonium chloride gel 
Biolab International Incorporated

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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Active Ingredient
Benzethonium Chloride 0.095%

Purpose

Antiseptic

Keep it out of children.

Directions: Place a small amount of product in your hand, and rub hands together until dry.

Inactive Ingredients: Water(EAU), Betaine Anhydrous,PEG-40 Hydrogenated Castor Oil, Phenoxyethanol,Diazolidinyl Urea, Palmitamidopropyltrimonium Chloride, Propylene Glycol, Fragrance(Parfum), Sodium Citric Acid, Disodium EDTA.

Storage: Avoid direct sunlight.

Uses

Decrease bacteria on hands.

WarningsFor external use only.

In case of contact with eyes, rinse immediately with plenty of water. Discontinue use if rash or irritation occurs and consult a doctor.

image of bottle label

HAND SANITIZER 
benzethonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72264-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.095 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
BETAINE (UNII: 3SCV180C9W)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
PALMITAMIDOPROPYLTRIMONIUM CHLORIDE (UNII: N2U96D202F)  
DISODIUM HYDROGEN CITRATE (UNII: 6FO62KCQ7A)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72264-001-01100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/18/2018
Labeler - Biolab International Incorporated (200167919)

Revised: 4/2018
Document Id: 6a3077a7-7462-e308-e053-2a91aa0a09d6
Set id: 6a3077a7-7461-e308-e053-2a91aa0a09d6
Version: 1
Effective Time: 20180418
 
Biolab International Incorporated