CERBERUS HAND SANITIZING GEL- alcohol gel 
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 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, 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. Flammable. Keep away from heat or flame

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

glycerin, aloe leaf juice, cellulose, thickener, essential oils, purified water USP

Package Label - Principal Display Panel

Cerberus Gallon480 mL NDC: 80892-003-16

3785 mL NDC: 80892-003-01 480mL Label

CERBERUS HAND SANITIZING GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80892-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
ALOE (UNII: V5VD430YW9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80892-003-16480 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/07/2020
2NDC:80892-003-013785 mL in 1 BOTTLE, DISPENSING; 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
FOUR FATHERS DISTILLERY LLC085564625manufacture(80892-003)
Establishment
NameAddressID/FEIBusiness Operations
GLOBAL CO PAK LLC117638624relabel(80892-003)

Revised: 11/2020
Document Id: b4e20a7d-c261-cb9f-e053-2a95a90a5c6a
Set id: b2346b4d-65da-feb0-e053-2995a90a9d10
Version: 2
Effective Time: 20201124
 
GLOBAL CO PAK LLC