FROZEN II BLUEBERRY SCENTED HAND SANITIZER 01- benzalkonium chloride gel 
FROZEN II BUBBLE GUM SCENTED HAND SANITIZER 01- benzalkonium chloride gel 
FROZEN II RASPBERRY SCENTED HAND SANITIZER 01- benzalkonium chloride gel 
TOYS STORY STRAWBERRY SCENTED HAND SANITIZER 01- benzalkonium chloride gel 
TOYS STORY GRAPE SCENTED HAND SANITIZER 01- benzalkonium chloride gel 
Townley Inc.

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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Drug facts

Active ingredient purpose

Benzalkonium chloride 0.1% Antibacterial

Use

To decrease bacteria on the skin that could cause disease.

Warnings

For external use only-hands

keep out of eyes- avoid contact with broken skin

Stop use and ask a dosctor if irritation or radness develops

Do not inhale or ingest. If swallowed, get medical help or contact a poison control right away.

Direction

Rub a dime sized drop into hands.

For children under 6 use under adult supervision

Inactive ingredients

INACTIVE INGREDIENTS: WATER, GLYCERIN, COCETH-7, PPG-1-PEG-9 LAURYL GLYCOL ETHER, CARBOMER, SODIUM HYDROXIDE, PEG-40 HYDROGENATED CASTOR OIL, FRAGRANCE (PARFUM).
MAY CONTAIN: RED 40, RED 33, BLUE 1, YELLOW 5.

Questions?

1-212-779-0544 weekdays

72005-012-0172005-011-0172005-010-0172005-009-0172005-008-01

FROZEN II BLUEBERRY SCENTED HAND SANITIZER  01
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72005-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCETH-7 (UNII: 58Y261JLH5) 0.68 mL  in 100 mL
PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L) 0.68 mL  in 100 mL
WATER O-18 (UNII: 7QV8F8BYNJ) 96 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.5 mL  in 100 mL
CARBOMER 934 (UNII: Z135WT9208) 0.24 mL  in 100 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.12 mL  in 100 mL
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) 0.15 mL  in 100 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.1 mL  in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.1 mL  in 100 mL
MYRISTICA FRAGRANS FRUIT (UNII: GOO22BTU71) 0.3 mL  in 100 mL
FD&C RED NO. 40 (UNII: WZB9127XOA) 0.1 mL  in 100 mL
D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.1 mL  in 100 mL
Product Characteristics
ColorblueScore    
ShapeSize
FlavorBLUEBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72005-008-0159 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package06/06/201904/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/06/201904/19/2021
FROZEN II BUBBLE GUM SCENTED HAND SANITIZER  01
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72005-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.5 mL  in 100 mL
COCETH-7 (UNII: 58Y261JLH5) 0.68 mL  in 100 mL
PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L) 0.68 mL  in 100 mL
CARBOMER 934 (UNII: Z135WT9208) 0.24 mL  in 100 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.12 mL  in 100 mL
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) 0.15 mL  in 100 mL
WATER O-18 (UNII: 7QV8F8BYNJ) 96 mL  in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.1 mL  in 100 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.1 mL  in 100 mL
MYRISTICA FRAGRANS FRUIT (UNII: GOO22BTU71) 0.3 mL  in 100 mL
D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.1 mL  in 100 mL
FD&C RED NO. 40 (UNII: WZB9127XOA) 0.1 mL  in 100 mL
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72005-009-0159 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package06/06/201904/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/06/201904/19/2021
FROZEN II RASPBERRY SCENTED HAND SANITIZER  01
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72005-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.15 mL  in 100 mL
COCETH-7 (UNII: 58Y261JLH5) 0.68 mL  in 100 mL
D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.1 mL  in 100 mL
MYRISTICA FRAGRANS FRUIT (UNII: GOO22BTU71) 0.3 mL  in 100 mL
FD&C RED NO. 40 (UNII: WZB9127XOA) 0.1 mL  in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.1 mL  in 100 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.1 mL  in 100 mL
WATER O-18 (UNII: 7QV8F8BYNJ) 96 mL  in 100 mL
CARBOMER 934 (UNII: Z135WT9208) 0.24 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.68 mL  in 100 mL
PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L) 0.68 mL  in 100 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.12 mL  in 100 mL
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72005-010-0159 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package06/06/201904/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/06/201904/19/2021
TOYS STORY STRAWBERRY SCENTED HAND SANITIZER  01
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72005-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER O-18 (UNII: 7QV8F8BYNJ) 96 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.5 mL  in 100 mL
COCETH-7 (UNII: 58Y261JLH5) 0.68 mL  in 100 mL
PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L) 0.68 mL  in 100 mL
CARBOMER 934 (UNII: Z135WT9208) 0.24 mL  in 100 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.12 mL  in 100 mL
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.15 mL  in 100 mL
MYRISTICA FRAGRANS FRUIT (UNII: GOO22BTU71) 0.3 mL  in 100 mL
FD&C RED NO. 40 (UNII: WZB9127XOA) 0.1 mL  in 100 mL
D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.1 mL  in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.1 mL  in 100 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.1 mL  in 100 mL
Product Characteristics
ColorredScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72005-011-0159 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package06/06/201904/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/06/201904/19/2021
TOYS STORY GRAPE SCENTED HAND SANITIZER  01
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72005-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER O-18 (UNII: 7QV8F8BYNJ) 96 mL  in 100 mL
COCETH-7 (UNII: 58Y261JLH5) 0.68 mL  in 100 mL
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.15 mL  in 100 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.12 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.5 mL  in 100 mL
PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L) 0.68 mL  in 100 mL
CARBOMER 934 (UNII: Z135WT9208) 0.24 mL  in 100 mL
MYRISTICA FRAGRANS FRUIT (UNII: GOO22BTU71) 0.3 mL  in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.1 mL  in 100 mL
FD&C RED NO. 40 (UNII: WZB9127XOA) 0.1 mL  in 100 mL
D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.1 mL  in 100 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.1 mL  in 100 mL
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72005-012-0159 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package06/06/201904/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/06/201904/19/2021
Labeler - Townley Inc. (016956158)
Registrant - Townley Inc. (016956158)
Establishment
NameAddressID/FEIBusiness Operations
Townley Inc.016956158pack(72005-008, 72005-009, 72005-010, 72005-011, 72005-012)

Revised: 4/2021
Document Id: c04f2013-f43f-19b6-e053-2a95a90a324e
Set id: 8af3ff39-871b-46cf-e053-2a95a90a1165
Version: 2
Effective Time: 20210419
 
Townley Inc.