CERBERUS ALCOHOL-FREE HAND SANITIZER- benzalkonium chloride aerosol, foam 
GLOBAL CO PAK 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(s)

Alcohol 0.13% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Do not use in eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask doctor if skin irritation develops.

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Citric acid, glycerin, lemongrass oil, water

Package Label - Principal Display Panel

473 mL NDC: 80892-005-16

473ml

3785 ml NDC: 80892-005-01

3785 mL

CERBERUS ALCOHOL-FREE HAND SANITIZER 
benzalkonium chloride aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80892-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80892-005-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/07/2020
2NDC:80892-005-013785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/07/2020
Labeler - GLOBAL CO PAK LLC (117638624)
Registrant - CERBERUS CRAFT DISTILLERY LLC (004160750)
Establishment
NameAddressID/FEIBusiness Operations
Environmental Manufacturing Solutions, LLC031863249manufacture(80892-005)
Establishment
NameAddressID/FEIBusiness Operations
GLOBAL CO PAK LLC117638624relabel(80892-005)

Revised: 12/2020
Document Id: b592a627-ebbb-ce60-e053-2a95a90a0127
Set id: b592a02c-0490-f4ae-e053-2995a90a7f93
Version: 1
Effective Time: 20201207
 
GLOBAL CO PAK LLC