BIOZONE by Biozone Chemical, S. de R.L. de C.V. BIOZONE- alcohol gel

BIOZONE by

Drug Labeling and Warnings

BIOZONE by is a Otc medication manufactured, distributed, or labeled by Biozone Chemical, S. de R.L. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT SECTION

Active ingredient Ethyl Alcohol 70%

DOSAGE AND ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry.

INACTIVE INGREDIENT SECTION

Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine

INDICATIONS AND USAGE SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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.

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.

PURPOSE

Purpose Antmicrobial

WARNINGS

Warnings

For external use only. Flammable. Keep away from heat or flame

WARNINGS AND PRECAUTIONS

Warnings

For external use only. Flammable. Keep away from heat or flame

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

ASK A DOCTOR

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

PACKAGE LABEL SECTION

INGREDIENTS AND APPEARANCE

BIOZONE 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78349-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	0.2585 mL  in 1 mL
TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253)	0.002 mL  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.0375 mL  in 1 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.002 mL  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78349-0003-1	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2021
2	NDC: 78349-0003-2	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2021
3	NDC: 78349-0003-3	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2021
4	NDC: 78349-0003-4	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2021
5	NDC: 78349-0003-5	3780 mL in 1 JUG; Type 0: Not a Combination Product	02/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/15/2021

Labeler - Biozone Chemical, S. de R.L. de C.V. (812910867)

Registrant - Biozone Chemical, S. de R.L. de C.V. (812910867)

Establishment
Name	Address	ID/FEI	Business Operations
Biozone Chemical, S. de R.L. de C.V.		812910867	manufacture(78349-0003)