FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Transformaciones Del Caribe, Sociedad Anonima
Effective date
2020-10-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:24

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Uses * Helps eliminated bacterias on hand. This product is not a substitute of soap hand washing. Avoid contact with broken and damaged skin

Dosage and administration

Directions: Place enough product in your palm to throughly cover your hands. Rubs hands together briskly until dry Children under 6 years of age should be supervised when using this product

Label contents#

Full prescribing information#

Uses

INDICATIONS & USAGE SECTION

Uses

* Helps eliminated bacterias on hand. This product is not a substitute of soap hand washing. Avoid contact with broken and damaged skin

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

  • Ethyl Alcohol 70%...................................Antiseptic

Warnings

WARNINGS SECTION

  • For external use only
  • When using this product avoid contact with eyes. In case of contact, flush with water for several minutes.
  • Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.
  • Stop use and ask Doctor: if skin irritation develops when using this product
  • Flammable: Keep away from heat and flame. Highly flammable liquid and vapor/

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

* Irritation develops while using this product

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Place enough product in your palm to throughly cover your hands.

  • Rubs hands together briskly until dry
  • Children under 6 years of age should be supervised when using this product

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, carbomer, propylene glycol, triethanolamine

Questions?

OTC - QUESTIONS SECTION

QUESTIONS OR COMMENTS: Phone: (786) 871-6663

Uses

OTC - PURPOSE SECTION

Uses

* Helps eliminated bacteria on hand. This product is not a substitute of soap hand washing. Avoid contact with broken and damaged skin

Hand Sanitizer Gel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78167-008-012022-07-29C16284748780-1e4f33bdf-a62b-d8a0-e053-dadaa90a6e4eInstant Hand Sanitizer Anti bacterial

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78167-008-01Hand Sanitizer7570.82 mL in 1 BOTTLE, PLASTICGEL7570.821

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78167-008HAND SANITIZER (ALCOHOL) GEL [TRANSFORMACIONES DEL CARIBE, SOCIEDAD ANONIMA]1Legacy NDC, 1 package rows20201011_b15583e3-d25b-0711-e053-2a95a90a19b0.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
78167-00878167-008-01

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
CARBOMER 934Z135WT9208IACT
PROPANEDIOL5965N8W85TIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
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
b1558431-f2d2-b9a4-e053-2995a90a9ea5b15583e3-d25b-0711-e053-2a95a90a19b02020-10-10WarningsExact identifier
spl id: b1558431-f2d2-b9a4-e053-2995a90a9ea5
spl set id: b15583e3-d25b-0711-e053-2a95a90a19b0

Reported adverse events (FAERS/openFDA)#

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