ANTIBACTERIAL LAVENDER SCENT- benzalkonium chloride liquid 
ANTIBACTERIAL LEMON SCENT- benzalkonium chloride liquid 
ANTIBACTERIAL WATERMELON SCENT- benzalkonium chloride liquid 
ANTIBACTERIAL- benzalkonium chloride liquid 
ANTIBACTERIAL COTTON SCENT- benzalkonium chloride liquid 
Protect U Guard LLC

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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Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Skin Antimicrobial

Uses

reduces amount of bacteria on hands

Warnings

For external use only: hands.

When using this product

do not use in or near eyes. In case of eye contact, flush thoroughly with water. Do not inhale or ingest.

Stop use and ask doctor if

irritation or redness develops. condition persists for more than 72 hours

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

Dispense an adequate amount in your palm to cover all surfaces of both hands completely. Scrub thoroughly for at least fifteen seconds. Rinse completely and dry

Inactive ingredients

Water, Lauramine Oxide, Glycerin, PEG-120 Methyl Glucose Dioleate, Parfum.

Questions or comments?

813-815-0530 or www.protectuguard.com

Antibacterial Soap 71788_017Lemon Soap 71788_018Lavender Soap 71788_019Watermelon Soap 71788_020Cotton Soap 71788_021

ANTIBACTERIAL LAVENDER SCENT 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71788-019
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
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
WATER (UNII: 059QF0KO0R)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71788-019-7024 in 1 CARTON12/02/2021
1NDC:71788-019-80100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:71788-019-5012 in 1 CARTON12/02/2021
2NDC:71788-019-60530 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3NDC:71788-019-104 in 1 CARTON12/02/2021
3NDC:71788-019-201000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/02/2021
ANTIBACTERIAL LEMON SCENT 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71788-018
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
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
WATER (UNII: 059QF0KO0R)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71788-018-7024 in 1 CARTON12/02/2021
1NDC:71788-018-80100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:71788-018-5012 in 1 CARTON12/02/2021
2NDC:71788-018-60530 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3NDC:71788-018-104 in 1 CARTON12/02/2021
3NDC:71788-018-201000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/02/2021
ANTIBACTERIAL WATERMELON SCENT 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71788-020
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
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
WATER (UNII: 059QF0KO0R)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71788-020-7024 in 1 CARTON12/02/2021
1NDC:71788-020-80100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:71788-020-5012 in 1 CARTON12/02/2021
2NDC:71788-020-60530 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3NDC:71788-020-104 in 1 CARTON12/02/2021
3NDC:71788-020-201000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/02/2021
ANTIBACTERIAL 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71788-017
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
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
WATER (UNII: 059QF0KO0R)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71788-017-7024 in 1 CARTON12/02/2021
1NDC:71788-017-80100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:71788-017-5012 in 1 CARTON12/02/2021
2NDC:71788-017-60530 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3NDC:71788-017-104 in 1 CARTON12/02/2021
3NDC:71788-017-201000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/02/2021
ANTIBACTERIAL COTTON SCENT 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71788-021
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
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
WATER (UNII: 059QF0KO0R)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71788-021-7024 in 1 CARTON12/02/2021
1NDC:71788-021-80100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:71788-021-5012 in 1 CARTON12/02/2021
2NDC:71788-021-60530 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3NDC:71788-021-104 in 1 CARTON12/02/2021
3NDC:71788-021-201000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/02/2021
Labeler - Protect U Guard LLC (080070945)
Establishment
NameAddressID/FEIBusiness Operations
Protect U Guard LLC080070945manufacture(71788-017, 71788-018, 71788-019, 71788-020, 71788-021)

Revised: 7/2023
Document Id: 01cf5d7a-5887-e8c6-e063-6294a90ab0d6
Set id: d21c108f-9cc1-46c9-e053-2995a90a2e7e
Version: 2
Effective Time: 20230731
 
Protect U Guard LLC