FDA.reportPublic FDA data

Fortaderm Antiseptic Hand Sanitizer Gel

Manufacturer
Forta Lab, S.A. de C.V.
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:23:28

Label at a glance#

ProductFortaderm Antiseptic Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

Flammable, keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

in the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Irritation and redness develop.
  • Condition persists for more than 72 hours.

Keep out of reach of children.

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.

Other information

SPL UNCLASSIFIED SECTION

  • Store in a cool, dry place at room temperature not above 86° F (30° C).
  • Do not leave exposed to the rays of the sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, glycerin, carbomer, triethanolamine.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78209-000-012025-01-30C16284748780-12cef2736-9c17-d83d-e063-dadaa90ab31fFortaderm Antiseptic Hand Sanitizer Gel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78209-000FORTADERM ANTISEPTIC HAND SANITIZER (ALCOHOL) GEL [FORTA LAB, S.A. DE C.V.]3Legacy NDC20231024_a9df688d-19d6-e79e-e053-2995a90ae3f3.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
78209-00078209-000-01

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
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
4aa417a4-a3ca-9b42-e063-6294a90aede9a9df688d-19d6-e79e-e053-2995a90ae3f32026-02-12WarningsExact identifier
spl set id: a9df688d-19d6-e79e-e053-2995a90ae3f3

Reported adverse events (FAERS/openFDA)#

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