HAND SANITIZER- alcohol gel

Colossus by

Drug Labeling and Warnings

Colossus by is a Otc medication manufactured, distributed, or labeled by Corporativo Concasa, S.A. de C.V., Isamar Topete. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 75% 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

• 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

Water, Triethanolamine (Trolamine), polyacrylic acid (carbomer)

Package Label - Principal Display Panel

236.56 mL NDC: 77766-001-01

Package Label - Principal Display Panel

3780 mL NDC code: 77766-001-02

Package Label

20000 mL NDC: 77766-001-03

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77766-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	760 mL  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)	5 mL  in 1000 mL
WATER (UNII: 059QF0KO0R)	240 mL  in 1000 mL
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)	4 mL  in 1000 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77766-001-01	236.56 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
2	NDC: 77766-001-02	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
3	NDC: 77766-001-03	20000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/15/2020

Labeler - Corporativo Concasa, S.A. de C.V. (814988515)

Registrant - Isamar Topete (814988515)

Establishment
Name	Address	ID/FEI	Business Operations
Corporativo Concasa, S.A. de C.V.		814988515	manufacture(77766-001)