FDA.reportPublic FDA data

Sani T 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 23:46:19

Label at a glance#

ProductSani T Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

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

Dosage and administration

Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

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

  • Keek 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 

OTC - STOP USE SECTION

if skin irritation occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, ger medical help in a PoisonControl Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product.

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

79410-003-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

79410-003-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle4Bottle4

79410-003-05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle5Bottle5

79410-003-06

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle6Bottle6

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN2
1041498ethanol 0.8 ML/ML Topical GelSCD2
1041498ethanol 80 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79410-003-032023-07-28C16284748780-10191ceaa-7005-198a-e063-dbdaa90aec3eSani T Hand Sanitizer
79410-003-042023-07-28C16284748780-10191ceaa-7005-198a-e063-dbdaa90aec3eSani T Hand Sanitizer
79410-003-052023-07-28C16284748780-10191ceaa-7005-198a-e063-dbdaa90aec3eSani T Hand Sanitizer
79410-003-062023-07-28C16284748780-10191ceaa-7005-198a-e063-dbdaa90aec3eSani T Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79410-003-03Sani T Hand Sanitizer125 mL in 1 BOTTLEGEL1252
79410-003-04Sani T Hand Sanitizer500 mL in 1 BOTTLEGEL5002
79410-003-05Sani T Hand Sanitizer1000 mL in 1 BOTTLEGEL10002
79410-003-06Sani T Hand Sanitizer3778 mL in 1 BOTTLE, PLASTICGEL37782

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79410-003SANI T HAND SANITIZER (ALCOHOL) GEL [CORPORATIVO CUBRETE, S.A. DE C.V.]2Legacy NDC, 4 package rows20220105_ad11ab2c-52dc-3ead-e053-2995a90a4599.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
79410-00379410-003-03, 79410-003-04, 79410-003-05, 79410-003-06

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
d4c5ead0-324b-6023-e053-2995a90a5d61ad11ab2c-52dc-3ead-e053-2995a90a45992022-01-04WarningsExact identifier
spl id: d4c5ead0-324b-6023-e053-2995a90a5d61
spl set id: ad11ab2c-52dc-3ead-e053-2995a90a4599

Reported adverse events (FAERS/openFDA)#

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