GFS BIOPROTECT HAND SANITIZER ALOE VERA- benzalkonium chloride gel 
GFS US LLC

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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DRUG FACTS

BioProtect Hand Sanitizer contains 0.13% antiseptic agent Benzalkonium Chloride formulated with Water,Hydroxyethyl Cellulose, Alkyl Polyglucoside, C12-C15 Pareth-3, 1-Ocatadecanaminium, N-N-dimethyl-N-[3-(trimethoxysilyl)propyl]-,chloride, Polyhexamethylene
Biguanide, Acetic Acid, Citronellol, Ammonia, Glycerin, Aloe Barbadensis (Aloe) Leaf Extract, and D and C Green No.5. It is alcohol-free, non-toxic and kills 99.99% of germs.

LabelBP_GEL

GFS BIOPROTECT HAND SANITIZER ALOE VERA 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76426-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)  
C12-15 PARETH-12 (UNII: 131316X18L)  
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
Acetic Acid (UNII: Q40Q9N063P)  
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
AMMONIA (UNII: 5138Q19F1X)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
D&C Green No. 5 (UNII: 8J6RDU8L9X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76426-012-0150 g in 1 BOTTLE, DISPENSING
2NDC:76426-012-02250 g in 1 BOTTLE, PUMP
3NDC:76426-012-031000 g in 1 BOTTLE
4NDC:76426-012-043790 g in 1 BOTTLE
5NDC:76426-012-05204116 g in 1 DRUM
6NDC:76426-012-06997903 g in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/26/2011
Labeler - GFS US LLC (967789228)

Revised: 4/2013
Document Id: a99bdb46-8246-4ff6-a5e1-5b25f896b06b
Set id: b79ac717-24dc-461f-9b97-60a41c2af565
Version: 8
Effective Time: 20130403
 
GFS US LLC