Label: GFS BIOPROTECT HAND SANITIZER ALOE VERA -- benzalkonium chloride spray
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Contains inactivated NDC Code(s)
NDC Code(s): 76426-011-01, 76426-011-02, 76426-011-03, 76426-011-04, view more76426-011-05, 76426-011-06, 76426-011-07, 76426-011-08, 76426-011-09, 76426-011-10, 76426-011-11, 76426-011-12 - Packager: GFS US LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 3, 2013
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DESCRIPTION
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.
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- GENERAL PRECAUTIONS
- WHEN USING
- STOP USE
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GFS BIOPROTECT HAND SANITIZER ALOE VERA -
benzalkonium chloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76426-011 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) DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4) C12-15 PARETH-12 (UNII: 131316X18L) POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF) CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL) .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF) SORBIC ACID (UNII: X045WJ989B) 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:76426-011-01 11 g in 1 BOTTLE, SPRAY 2 NDC:76426-011-02 28 g in 1 BOTTLE, SPRAY 3 NDC:76426-011-03 55 g in 1 BOTTLE, SPRAY 4 NDC:76426-011-04 110 g in 1 BOTTLE, SPRAY 5 NDC:76426-011-05 225 g in 1 BOTTLE, SPRAY 6 NDC:76426-011-06 1000 g in 1 BOTTLE 7 NDC:76426-011-07 3790 g in 1 BOTTLE 8 NDC:76426-011-08 204300 g in 1 DRUM 9 NDC:76426-011-09 2204600 g in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK 10 NDC:76426-011-10 800 g in 1 BAG 11 NDC:76426-011-11 1200 g in 1 BAG 12 NDC:76426-011-12 1800 g in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/20/2011 Labeler - GFS US LLC (967789228)