PRE FENSE UNSCENTED- benzalkonium chloride liquid 
Prefense LLC

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Prefense Unscented Hand Sanitizer

Hand and Skin Sanitizer

Drug Facts

Active Ingredient

Benzalkonium Chloride ............0.12%

Hand sanitizer to help reduce germs that potentially cause disease.

For external use only. Avoid contact with eyes. In case of eye contact, flush with water. Discontinue use if irritation or redness occurs.

Keep out of reach of children.

Apply to dry hands, rub together, and let dry.

3-Chloropropyltrimethoxysilane, Acetic Acid, Anhydrous Citric Acid, Cocomidoprophyl betaine, Octadecyldimethyl (3-trimethoxysilylpropyl)ammonium chloride, Isotonic Sodium Chloride Solution, Water

Package Label - 1.5 FL. OZ. BOTTLE LABEL

pre•fense ™

Hand Sanitizer

Unscented

protects

kills up to 99.99% of germs on contact

Moisturizes

silica based, alcohol-free

alcohol-free

won't dry out skin

120 Pumps

1.5 fl. oz.

1

PRE FENSE UNSCENTED 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48404-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE120 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
WATER (UNII: 059QF0KO0R)  
(3-CHLOROPROPYL)TRIMETHOXYSILANE (UNII: T21BNL1S7F)  
ISOTONIC SODIUM CHLORIDE SOLUTION (UNII: VR5Y7PDT5W)  
METHYL ALCOHOL (UNII: Y4S76JWI15)  
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)  
ACETIC ACID (UNII: Q40Q9N063P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48404-050-0144.4 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
2NDC:48404-050-02236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
3NDC:48404-050-03502.8 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)05/15/2020
Labeler - Prefense LLC (832498625)
Registrant - Prefense LLC (832498625)
Establishment
NameAddressID/FEIBusiness Operations
Reynolds Engineering807186333manufacture(48404-050) , label(48404-050) , pack(48404-050)

Revised: 11/2023
Document Id: 0930bf8b-2181-fadc-e063-6394a90adc78
Set id: a59e9bbf-b60e-970a-e053-2a95a90aaa5e
Version: 3
Effective Time: 20231102
 
Prefense LLC