FDA.reportPublic FDA data

Antiseptic Hand Sanitizer Gel

Manufacturer
Global-C Nederland B.V.
Effective date
2020-08-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:18:38

Label at a glance#

ProductAntiseptic Hand Sanitizer Gel
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

Wet hand 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

OTC - STOP USE SECTION

  • irritation and redness develops
  • 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 hand thoroughly with product and allow to dry without wiping.

Other information:

SPL UNCLASSIFIED SECTION

Store below 77ºF (25ºC)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alpha tocopheryl acetate, monopropylene glycol, peg-7 glycerylic acid, triclosan, triethanolamine, water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

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
78657-00578657-005-29

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
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TRICLOSAN4NM5039Y5XIACT
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
08598841-54df-d55b-e063-6294a90a51f8acae5e0b-4c35-1549-e053-2a95a90a69832023-10-22WarningsExact identifier
spl set id: acae5e0b-4c35-1549-e053-2a95a90a6983

Reported adverse events (FAERS/openFDA)#

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