FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Tu Negocio En Minutos SA de CV
Effective date
2020-08-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:19:17

Label at a glance#

ProductHand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

Storage and handling

Do not store above105oF, may discolor some fabrics, Harmful to wood finishes and plastics.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. TRIETHANOLAMINE BENZOATE (0.125% v/v).
  4. Carbomer 940 0.5%
  5. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.3mL..........Antimicrobial

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin that could cause disease, Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only: hands Do not drink

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

Keep out of eyes in case of contact with eyes, flush thoroughly with water, Avoid contact with broken skin,

Do not inhale or ingest.

OTC - STOP USE SECTION

Skin irritation develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center Right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

Other information

STORAGE AND HANDLING SECTION

Do not store above105oF, may discolor some fabrics, Harmful to wood finishes and plastics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Triethanolamine, Purified Water, Fragance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mL500 mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79219-002-012025-11-13C16284748780-1d6a99b39-df0f-a426-e053-dadaa90af4c2Tahor Alcohol-Free 500 mL
79219-002-012022-01-28C16284748780-1d6a99b39-df0f-a426-e053-dadaa90af4c2Tahor Alcohol-Free 500 mL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79219-002HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [TU NEGOCIO EN MINUTOS SA DE CV]3Legacy NDC20200806_abfe5fdd-e5aa-bd2c-e053-2995a90a2168.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
79219-00279219-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIETHANOLAMINE BENZOATEM3EN4GC19WIACT
WATER059QF0KO0RIACT
CARBOMER 9404Q93RCW27EIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
437e6c45-e003-35ec-e063-6394a90a7874abfe5fdd-e5aa-bd2c-e053-2995a90a21682025-11-13WarningsExact identifier
spl set id: abfe5fdd-e5aa-bd2c-e053-2995a90a2168

Reported adverse events (FAERS/openFDA)#

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