CERBERUS ALCOHOL-FREE HAND SANITIZER- benzalkonium chloride aerosol, foam

Cerberus Alcohol-Free Hand Sanitizer by

Drug Labeling and Warnings

Cerberus Alcohol-Free Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by GLOBAL CO PAK LLC, CERBERUS CRAFT DISTILLERY LLC, Environmental Manufacturing Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• in children less than 2 months of age
• on open skin wounds

WHEN USING

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

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

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

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Citric acid, glycerin, lemongrass oil, water

Package Label - Principal Display Panel

473 mL NDC: 80892-005-16

3785 ml NDC: 80892-005-01

INGREDIENTS AND APPEARANCE

CERBERUS ALCOHOL-FREE HAND SANITIZER 
benzalkonium chloride aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80892-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80892-005-16	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/07/2020
2	NDC: 80892-005-01	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/07/2020

Labeler - GLOBAL CO PAK LLC (117638624)

Registrant - CERBERUS CRAFT DISTILLERY LLC (004160750)

Establishment
Name	Address	ID/FEI	Business Operations
Environmental Manufacturing Solutions, LLC		031863249	manufacture(80892-005)

Establishment
Name	Address	ID/FEI	Business Operations
GLOBAL CO PAK LLC		117638624	relabel(80892-005)