Label: BYOTROL ANTIBACTERIAL FOAMING HAND SANITIZER- benzalkonium chloride liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 42719-346-06, 42719-346-50, 42719-346-51, 42719-346-99 - Packager: Byotrol, Inc.
- 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 March 8, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
-
PRINCIPAL DISPLAY PANEL
100%
Hygeine
Revolution
Byotrol
Alcohol Free
Kills Germs
Antibacterial Foaming
Hand Sanitizer
Powerful
No other FDA compliant hand antiseptic claims more.
Long Lasting
Foaming formula lasts, increasing wet contact time, to deliver the persistent performance Byotrol is known for.
Gentle
Alcohol Free Formula is hard on germs and soft on hands.
byotrol
Net Contents: 42.26 fl.Oz. (1,250ml)
-
INGREDIENTS AND APPEARANCE
BYOTROL ANTIBACTERIAL FOAMING HAND SANITIZER
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42719-346 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC) GLYCERETH-17 COCOATE (UNII: 3057VPT0KC) DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5) POLIHEXANIDE (UNII: 322U039GMF) C12-15 PARETH-7 (UNII: 3XY03A79QH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42719-346-50 500 mL in 1 BOTTLE 2 NDC:42719-346-51 210 mL in 1 BOTTLE 3 NDC:42719-346-99 50 mL in 1 BOTTLE 4 NDC:42719-346-06 1250 mL in 1 CARTRIDGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/08/2013 Labeler - Byotrol, Inc. (084600340) Establishment Name Address ID/FEI Business Operations Bayscience Formulators Inc. 162930544 manufacture(42719-346)