COLABORATORY HAND SANITIZER- alcohol solution

CoLaboratory Hand Sanitizer by

Drug Labeling and Warnings

CoLaboratory Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Doehler USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl Alcohol v/v 70%

Purpose

Antiseptic

USE

• Hand sanitizer to help reduce bacteria that could potentially cause disease. For use when soap and water are not readily available.

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product

• Avoid contact with eyes. If contact occurs, flush eyes with water.
• Avoid contact with broken skin.

Stop use and consult doctor if irritation and redness develop and last.

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

Directions

• Wet hands with product and allow to dry without wiping.
• For children under 6, use only under adult supervision.
• Not recommended for infants.

Other information

• Store below 83°F (26.6°C
• May discolor certain fabrics or surfaces

Inactive ingredients:

Acrylates Copolymer, Glycerin, Hydrogen Peroxide, Sodium Hydroxide, Water

SPL UNCLASSIFIED SECTION

alcohol antiseptic 70%

topical solution

non-sterile solution

Doehler North America
400 High Point Road SE
Cartersville, GA

for consumer complaints
please call 770 387 0451
select the prompt to customer service

Packaging

INGREDIENTS AND APPEARANCE

COLABORATORY HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77278-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77278-001-01	1.83 L in 1 BOTTLE; Type 0: Not a Combination Product	06/03/2020
2	NDC: 77278-001-02	3.67 L in 1 BOTTLE; Type 0: Not a Combination Product	06/03/2020
3	NDC: 77278-001-03	18.93 L in 1 PAIL; Type 0: Not a Combination Product	06/03/2020
4	NDC: 77278-001-04	208.2 L in 1 DRUM; Type 0: Not a Combination Product	06/03/2020
5	NDC: 77278-001-05	999.4 L in 1 CONTAINER; Type 0: Not a Combination Product	06/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/03/2020

Labeler - Doehler USA Inc. (040455356)

Establishment
Name	Address	ID/FEI	Business Operations
Doehler USA Inc.		040455356	manufacture(77278-001)