NDC Code(s) : 65601-700-53, 65601-700-29, 65601-700-04, 65601-700-57, 65601-700-55, 65601-700-03, 65601-700-05, 65601-700-88
Packager : Betco Corporation, Ltd.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alcohol Free Foaming Hand SanitizerBenzalkonium Chloride SOAP
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65601-700
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
(BENZALKONIUM - UNII:7N6JUD5X6Y) 		BENZALKONIUM CHLORIDE1.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
.GAMMA.-TERPINENE(UNII: 4YGF4PQP49)
BUTYLPHENYL METHYLPROPIONAL(UNII: T7540GJV69)
MAGNESIUM NITRATE(UNII: 77CBG3UN78)
.BETA.-CITRONELLOL, (+/-)-(UNII: 565OK72VNF)
METHYLCHLOROISOTHIAZOLINONE(UNII: DEL7T5QRPN)
CYCLOMETHICONE 4(UNII: CZ227117JE)
ACETALDEHYDE(UNII: GO1N1ZPR3B)
GERANIOL(UNII: L837108USY)
HEXAMETHYLINDANOPYRAN(UNII: 14170060AT)
METHYL DIHYDROJASMONATE (SYNTHETIC)(UNII: 3GW44CIE3Y)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18)(UNII: 9U1Q4T4ZYS)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
D&C GREEN NO. 5(UNII: 8J6RDU8L9X)
PEG/PPG-15/15 ALLYL ETHER ACETATE(UNII: 8RP39FN7AJ)
HEXYL SALICYLATE(UNII: 8F78EY72YL)
ALCOHOL(UNII: 3K9958V90M)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
WATER(UNII: 059QF0KO0R)
PEG-6 COCAMIDE(UNII: YZ6NLA4O1E)
.ALPHA.-PINENE(UNII: JPF3YI7O34)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
NEROL(UNII: 38G5P53250)
2-METHYL-3-(P-METHOXYPHENYL)PROPANAL(UNII: L7QWJ4USPC)
LIMONENE, (+)-(UNII: GFD7C86Q1W)
HEXYL CINNAMAL(UNII: 7X6O37OK2I)
ALLYL CYCLOHEXANEPROPIONATE(UNII: H4W9H3L241)
Product Characteristics
Color blue Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65601-700-5350 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product01/01/2016
2NDC:65601-700-291000 mL in 1 BAG Type 0: Not a Combination Product01/01/2016
3NDC:65601-700-043780 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/01/2016
4NDC:65601-700-57550 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product01/01/2016
5NDC:65601-700-55207900 mL in 1 DRUM Type 0: Not a Combination Product01/01/2016
6NDC:65601-700-03750 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product15/09/2016
7NDC:65601-700-051250 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product15/09/2016
8NDC:65601-700-88500 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product11/12/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug 505G(a)(3) 11/12/2012

LABELER - Betco Corporation, Ltd.(005050158)

REGISTRANT - Betco corporation, Ltd.(005050158)

Establishment
Name Address ID/FEI Business Operations
Betco Corporation, Ltd. 005050158 manufacture(65601-700), label(65601-700)

PRINCIPAL DISPLAY PANEL

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