GFS BIOPROTECT HAND SANITIZER ALOE VERA- benzalkonium chloride gel

GFS BioProtect Hand Sanitizer Aloe Vera by

Drug Labeling and Warnings

GFS BioProtect Hand Sanitizer Aloe Vera by is a Otc medication manufactured, distributed, or labeled by GFS US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

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.

ACTIVE INGREDIENT

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

PURPOSE

• Antiseptic

INDICATIONS & USAGE

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

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

GENERAL PRECAUTIONS

• Review MSDS before handling the product

WHEN USING

• 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

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

INACTIVE INGREDIENT

• 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; AloeBarbadensis (Aloe) Leaf Extract;  D and C Green No.5

PRINCIPAL DISPLAY PANEL

Label

INGREDIENTS AND APPEARANCE

GFS BIOPROTECT HAND SANITIZER ALOE VERA 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76426-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76426-012-01	50 g in 1 BOTTLE, DISPENSING
2	NDC: 76426-012-02	250 g in 1 BOTTLE, PUMP
3	NDC: 76426-012-03	1000 g in 1 BOTTLE
4	NDC: 76426-012-04	3790 g in 1 BOTTLE
5	NDC: 76426-012-05	204116 g in 1 DRUM
6	NDC: 76426-012-06	997903 g in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/26/2011

Labeler - GFS US LLC (967789228)