GFS HAND SANITIZER ALOE VERA  - benzalkonium chloride spray 
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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BioProtect Hand Sanitizer contains 0.13% antiseptic agent Benzalkonium Chloride formulated with  Water,1-Ocatadecanaminium, N-N-dimethyl-N-[3-(trimethoxysilyl)propyl]-,chloride, C12-C15 Pareth-3, Polyaminopropyl biguanide, Caprylyl glucoside, Citronellol, Sorbic Acid, 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.

Benzalkonium Chloride 0.13%.............................................Antiseptic

  • Antispetic

  • Hand sanitizer to help decrease bacteria on skin
  • Recommended for repeated use

  • For external use only
  • Do not use in ears or mouth

  • Keep out of reach on children
  • Children must be supervised in use of this product

  • Apply a small amount into your palm and thoroughly spread on both hands
  • Rub into skin until dry

  • Review MSDS before handling the product

  • When using this product do not use in ears or mouth
  • Avoid contact with eyes
  • In case of eye contact, rinse eyes thoroughly with water

  • Stop use and ask a doctor if skin irritation or redness develops and persists for more than 72 hours

Water,1-Ocatadecanaminium, N-N-dimethyl-N-[3-(trimethoxysilyl)propyl]-,chloride, C12-C15 Pareth-3, Polyaminopropyl biguanide, Caprylyl glucoside, Citronellol, Sorbic Acid, Glycerin, Aloe Barbadensis (Aloe) Leaf Extract, and  D and C Green No.5

GFS_SPRAY
GFS HAND SANITIZER ALOE VERA  
benzalkonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76426-011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (Benzalkonium) Benzalkonium Chloride0.0013 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water0.9677 g  in 1 g
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE0.01 g  in 1 g
POLYAMINOPROPYL BIGUANIDE0.005 g  in 1 g
CAPRYLYL GLUCOSIDE0.003 g  in 1 g
.BETA.-CITRONELLOL, (+/-)-0.003 g  in 1 g
SORBIC ACID0.003 g  in 1 g
GLYCERIN0.001 g  in 1 g
ALOE VERA LEAF0.0005 g  in 1 g
D&C Green No. 50.0005 g  in 1 g
Packaging
#Item CodePackage Description
1NDC:76426-011-0111 g in 1 BOTTLE, SPRAY
2NDC:76426-011-0228 g in 1 BOTTLE, SPRAY
3NDC:76426-011-0355 g in 1 BOTTLE, SPRAY
4NDC:76426-011-04110 g in 1 BOTTLE, SPRAY
5NDC:76426-011-05225 g in 1 BOTTLE, SPRAY
6NDC:76426-011-061000 g in 1 BOTTLE
7NDC:76426-011-073790 g in 1 BOTTLE
8NDC:76426-011-08204300 g in 1 DRUM
9NDC:76426-011-092204600 g in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
10NDC:76426-011-10800 g in 1 BAG
11NDC:76426-011-111200 g in 1 BAG
12NDC:76426-011-121800 g in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/20/2011
Labeler - GFS US LLC (967789228)

Revised: 11/2011
Document Id: 78bf314e-034d-4855-9821-fe5da27a550a
Set id: 796876f1-2f13-46a2-a410-37438a4de02d
Version: 5
Effective Time: 20111101
 
GFS US LLC