BIOZONE HAND SANITIZER GEL

Manufacturer
Biozone Chemical, S. de R.L. de C.V.
Effective date
2021-02-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:10

Label at a glance#

ProductBIOZONE
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

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.

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Ethyl Alcohol 70%

DOSAGE AND ADMINISTRATION SECTION

DOSAGE & 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

INDICATIONS & 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

PURPOSE

OTC - PURPOSE SECTION

Purpose Antmicrobial

WARNINGS

WARNINGS SECTION

Warnings

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

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

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

OTC - ASK DOCTOR SECTION

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

PACKAGE LABEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-137502228648093GTIN-13: 7502228648093
EAN-13: 7502228648093
GTIN storage (14 digits): 07502228648093
HAND SANITIZER BIOZONE 60ml.jpg

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78349-0003-1BIOZONE60 mL in 1 BOTTLEGEL601
78349-0003-2BIOZONE180 mL in 1 BOTTLEGEL1801
78349-0003-3BIOZONE250 mL in 1 BOTTLEGEL2501
78349-0003-4BIOZONE1000 mL in 1 BOTTLEGEL10001
78349-0003-5BIOZONE3780 mL in 1 JUGGEL37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78349-0003BIOZONE (ALCOHOL) GEL [BIOZONE CHEMICAL, S. DE R.L. DE C.V.]1Legacy NDC, 5 package rows20210216_bb6e55c9-cd36-01db-e053-2a95a90a8af7.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78349-000378349-0003-1, 78349-0003-2, 78349-0003-3, 78349-0003-4, 78349-0003-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bb6e55c9-cd37-01db-e053-2a95a90a8af7bb6e55c9-cd36-01db-e053-2a95a90a8af72021-02-16WarningsExact identifier
spl id: bb6e55c9-cd37-01db-e053-2a95a90a8af7
spl set id: bb6e55c9-cd36-01db-e053-2a95a90a8af7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.