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

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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BIOZONE HAND SANITIZER GEL

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

HAND SANITIZER BIOZONE 60ml.jpgHAND SANITIZER BIOZONE 180ml.jpgHAND SANITIZER BIOZONE 250ml.jpgHAND SANITIZER BIOZONE 1000ml.jpgHAND SANITIZER BIOZONE 3780ml.jpg

BIOZONE 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78349-0003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78349-0003-160 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2021
2NDC:78349-0003-2180 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2021
3NDC:78349-0003-3250 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2021
4NDC:78349-0003-41000 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2021
5NDC:78349-0003-53780 mL in 1 JUG; Type 0: Not a Combination Product02/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/15/2021
Labeler - Biozone Chemical, S. de R.L. de C.V. (812910867)
Registrant - Biozone Chemical, S. de R.L. de C.V. (812910867)
Establishment
NameAddressID/FEIBusiness Operations
Biozone Chemical, S. de R.L. de C.V.812910867manufacture(78349-0003)

Revised: 2/2021
Document Id: bb6e55c9-cd37-01db-e053-2a95a90a8af7
Set id: bb6e55c9-cd36-01db-e053-2a95a90a8af7
Version: 1
Effective Time: 20210216
 
Biozone Chemical, S. de R.L. de C.V.