FDA.reportPublic FDA data

Immunotec Hand Sanitizer

Manufacturer
Corporativo Cubrete, S.A. de C.V.
Effective date
2022-01-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:46:20

Label at a glance#

ProductImmunotec Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

  • Hand Sanitizer to help reduce bacteria that potentially cause disease.
  • For use when soap and water are not available.

Warnings

WARNINGS SECTION

Flammable

  • Keep away from fire or flame.

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Do not use it in or near the eyes
  • In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if 

OTC - STOP USE SECTION

skin irritation occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help in a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Other information

SPL UNCLASSIFIED SECTION

  • Store below 110°F (43°C)
  • May discolor certain fabrics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Triethanolamine, Carbomer, Polysorbate, Water, Glycerin.

Questions?

OTC - QUESTIONS SECTION

+52 1 56 1876 7678 Info@cubret.mx

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79410-004-012023-07-28C16284748780-10191ceaa-6112-198a-e063-dbdaa90aec3eImmunotec Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79410-004-01Immunotec Hand Sanitizer250 mL in 1 BOTTLEGEL2502
79410-004-01Immunotec Hand Sanitizer20 in 1 BOXGEL202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79410-004IMMUNOTEC HAND SANITIZER (ALCOHOL) GEL [CORPORATIVO CUBRETE, S.A. DE C.V.]2Legacy NDC, 2 package rows20220105_ae58692c-809c-6099-e053-2995a90a6966.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
79410-00479410-004-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
TROLAMINE9O3K93S3TKIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB

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
d4c60d7a-7aff-59ac-e053-2995a90a37c9ae58692c-809c-6099-e053-2995a90a69662022-01-04WarningsExact identifier
spl id: d4c60d7a-7aff-59ac-e053-2995a90a37c9
spl set id: ae58692c-809c-6099-e053-2995a90a6966

Reported adverse events (FAERS/openFDA)#

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