FDA.reportPublic FDA data

Antiseptic Hand Sanitizer Gel

Manufacturer
ADA COSMETICS INTERNATIONAL SDN. BHD.
Effective date
2021-08-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:38:56

Label at a glance#

ProductAntiseptic Hand Sanitizer Gel
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 79%

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 at temperature below 110°F (43°C)
  • May discolor certain fabrics or surfaces

nactive ingredients

INACTIVE INGREDIENT SECTION

Water, glycerin, fragrance, butylphenyl methylpropional, benzyl salicylate, citral, geraniol, hexyl cinnamal, limonene, linalool, phenoxyethanol, panthenol, acrylates/C10-30 alkyl acrylate crosspolymer, aminomethyl propanol

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label FrontLabel FrontLabel BackLabel Back

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80649-00280649-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
BUTYLPHENYL METHYLPROPIONALT7540GJV69IACT
BENZYL SALICYLATEWAO5MNK9TUIACT
CITRALT7EU0O9VPPIACT
GERANIOLL837108USYIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PANTHENOLWV9CM0O67ZIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
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
de58391c-a201-9372-e053-2a95a90ab0e7c8d4b725-9d26-0b59-e053-2995a90a06c22022-05-06WarningsExact identifier
spl set id: c8d4b725-9d26-0b59-e053-2995a90a06c2

Reported adverse events (FAERS/openFDA)#

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