HAND SANITIZER

Manufacturer
Biozone Chemical, S. de R.L. de C.V.
Effective date
2020-05-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:32

Label at a glance#

ProductHAND SANITIZER
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

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Ethyl Alcohol 70%

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

INDICATIONS AND USAGE

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

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.

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.

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.

ASK DOCTOR

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if irritation or rash occurs

PACKAGING LABELS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL 250 mLLABEL 250 mLLABEL 500 mLLABEL 500 mLLABEL 1000 mLLABEL 1000 mLLABEL 400 mLLABEL 400 mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78349-0002-22022-01-28C16284748780-1d6a99b39-731e-a426-e053-dadaa90af4c2HAND SANITIZER
78349-0002-32022-01-28C16284748780-1d6a99b39-731e-a426-e053-dadaa90af4c2HAND SANITIZER
78349-0002-42022-01-28C16284748780-1d6a99b39-731e-a426-e053-dadaa90af4c2HAND SANITIZER
78349-0002-52022-01-28C16284748780-1d6a99b39-731e-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78349-0002-2HAND SANITIZER250 mL in 1 BOTTLEGEL2501
78349-0002-3HAND SANITIZER500 mL in 1 BOTTLEGEL5001
78349-0002-4HAND SANITIZER1000 mL in 1 BOTTLEGEL10001
78349-0002-5HAND SANITIZER4000 mL in 1 BOTTLEGEL40001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78349-0002HAND SANITIZER (ALCOHOL) GEL [BIOZONE CHEMICAL, S. DE R.L. DE C.V.]1Legacy NDC, 4 package rows20200525_a67127a7-d20e-8843-e053-2a95a90a27f9.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
78349-000278349-0002-2, 78349-0002-3, 78349-0002-4, 78349-0002-5

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
a67127a7-d20f-8843-e053-2a95a90a27f9a67127a7-d20e-8843-e053-2a95a90a27f92020-05-24WarningsExact identifier
spl id: a67127a7-d20f-8843-e053-2a95a90a27f9
spl set id: a67127a7-d20e-8843-e053-2a95a90a27f9

Reported adverse events (FAERS/openFDA)#

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