FDA.reportPublic FDA data

Antiseptic Hand Sanitizer

Manufacturer
V-Shapes Srl
Effective date
2020-05-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:37

Label at a glance#

ProductAntiseptic Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure7 sections

Indications and uses

for hand washing to decrease bacteria on the skin recommended for repeated use

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

Isopropyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • for hand washing to decrease bacteria on the skin
  • recommended for repeated use

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 or Comments?

OTC - QUESTIONS SECTION

+1 (888) 408-1694

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner PackageBoxBox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581698isopropyl alcohol 70 % Topical GelPSN1
581698isopropyl alcohol 0.7 ML/ML Topical GelSCD1
581698isopropyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74785-000-002022-01-28C16284748780-1d6a99b39-56dc-a426-e053-dadaa90af4c2Antiseptic Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74785-000-00Antiseptic Hand Sanitizer250 in 1 BOXGEL2501
74785-000-00Antiseptic Hand Sanitizer1.5 mL in 1 DOSE PACKGEL1.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74785-000ANTISEPTIC HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [V-SHAPES SRL]1Legacy NDC, 2 package rows20200505_a4d7b414-ef71-b2e7-e053-2a95a90ada12.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
74785-00074785-000-00

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
ISOPROPYL ALCOHOLND2M416302ACTIB

Source Document#

Source XML · Source PDF

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
a4d7bc53-cffb-7f55-e053-2995a90a2d1ca4d7b414-ef71-b2e7-e053-2a95a90ada122020-05-04WarningsExact identifier
spl id: a4d7bc53-cffb-7f55-e053-2995a90a2d1c
spl set id: a4d7b414-ef71-b2e7-e053-2a95a90ada12

Reported adverse events (FAERS/openFDA)#

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