FDA.reportPublic FDA data

Antiseptic Hand sanitizer VERSACE

Manufacturer
V-SHAPES SRL | Orlandi Inc. | Accurate Labs, LLC
Effective date
2020-07-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:23:02

Label at a glance#

ProductAntiseptic Hand sanitizer VERSACE
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 80%

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, imidazolidinyl urea, PEG-12 dimethicone, propylene chlorhexidine gluconate, triethanolamine, water.

Questions?

OTC - QUESTIONS SECTION

1-(888) 408-1694

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box Label4Box Label4Inner Label4Inner Label4

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
74785-003-002022-01-28C16284748780-1d6a99b39-925d-a426-e053-dadaa90af4c2Antiseptic Hand sanitizer VERSACE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74785-003-00Antiseptic Hand sanitizer VERSACE3 mL in 1 PACKAGEGEL32
74785-003-00Antiseptic Hand sanitizer VERSACE5 in 1 BOXGEL52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74785-003ANTISEPTIC HAND SANITIZER VERSACE (ALCOHOL) GEL [V-SHAPES SRL]2Legacy NDC, 2 package rows20200729_b2dffe98-b455-4e2c-99a1-b87fd8769382.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74785-00374785-003-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
IMIDUREAM629807ATLIACT
PEG-12 DIMETHICONE (300 CST)ZEL54N6W95IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
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
ab84b70c-471e-8968-e053-2a95a90af161b2dffe98-b455-4e2c-99a1-b87fd87693822020-07-28WarningsExact identifier
spl id: ab84b70c-471e-8968-e053-2a95a90af161
spl set id: b2dffe98-b455-4e2c-99a1-b87fd8769382

Reported adverse events (FAERS/openFDA)#

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