ALCOHOL FREE FOAMING HAND SANITIZER- benzalkonium chloride soap 
Betco Corporation, Ltd.

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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Alcohol Free Foaming Hand Sanitizer

Alcohol Free Foaming Hand Sanitizer

​Active Ingredient

Benzalkonium Chloride 0.13%

Alcohol Free Foaming Hand Sanitizer

Uses

Alcohol Free Foaming Hand Sanitizer

Warnings

Alcohol Free Foaming Hand Sanitizer

Directions

Alcohol Free Foaming Hand Sanitizer

Inactive Ingredients

Deionized ​Water, Sodium PCA, PEG/PPG-8/3 Laurate, Dimethicone,  PEG-3 Cocamide, Fragrance, Methyl Chloro Isothiazolinone, Methyl Isothiazolinone,  D&C Green #5.

Alcohol Free Foaming Hand Sanitizer

Questions or Comments?Phone: (800) 777-9343

MDS information:​(800) 891-4965

Alcohol Free Foaming Hand Sanitizer

Purpose

Antiseptic

Alcohol Free Foaming Hand Sanitizer

KEEP OUT OF REACH OF CHILDREN

Alcohol Free Foaming Hand Sanitizer

5329880455

ALCOHOL FREE FOAMING HAND SANITIZER 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-700
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GRAPEFRUIT OIL (UNII: YR377U58W9)  
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)  
DIHYDROMYRCENOL (UNII: 46L1B02ND9)  
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
MYRCENE (UNII: 3M39CZS25B)  
SODIUM PIDOLATE (UNII: 1V74VH163T)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18) (UNII: 9U1Q4T4ZYS)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
ORANGE OIL (UNII: AKN3KSD11B)  
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
PEG/PPG-15/15 ALLYL ETHER ACETATE (UNII: 8RP39FN7AJ)  
HEXYL SALICYLATE (UNII: 8F78EY72YL)  
ALCOHOL (UNII: 3K9958V90M)  
LIME OIL (UNII: UZH29XGA8G)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
WATER (UNII: 059QF0KO0R)  
DIOXANE (UNII: J8A3S10O7S)  
PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
LEMON OIL (UNII: I9GRO824LL)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing 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 Product01/01/201609/11/2020
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 Product09/15/201607/15/2020
7NDC:65601-700-051250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/15/201609/11/2020
8NDC:65601-700-88500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/12/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/12/2012
Labeler - Betco Corporation, Ltd. (024492831)
Registrant - Betco corporation, Ltd. (024492831)
Establishment
NameAddressID/FEIBusiness Operations
Betco Corporation, Ltd.024492831manufacture(65601-700) , pack(65601-700) , label(65601-700)

Revised: 9/2020
Document Id: af0b7728-2cb3-d5d7-e053-2995a90ab29e
Set id: 7e038b0a-4813-4f4b-ad66-0584d75a064f
Version: 11
Effective Time: 20200911
 
Betco Corporation, Ltd.