FDA.reportPublic FDA data

Mandarin Orange Scented Antiseptic Hand Sanitizer Spray 80 % Ethyl Alcohol

Manufacturer
H&Y Products LLC dba Kolonya Carre
Effective date
2023-12-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:16:31

Label at a glance#

ProductMandarin Orange Scented Antiseptic Hand Sanitizer 80 Ethyl Alcohol
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 onlyFlammable, 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

Water, Fragrance, Alpha isomethyl ionone, Benzyl salicylate, Butylphenyl methylpropional, Citral, Citronellol, Coumarin, Limonene, Linalool

Package Labeling:82127-004-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package9Outer Package9Inner Package9Inner Package9

Package Labeling:82127-004-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package10Outer Package10Inner Package10Inner Package10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82127-004MANDARIN ORANGE SCENTED ANTISEPTIC HAND SANITIZER 80 ETHYL ALCOHOL (ALCOHOL) LIQUID [H&Y PRODUCTS LLC DBA KOLONYA CARRE]3Legacy NDC20231230_eef49bc3-a75c-4168-9cb3-4f533ea2ab45.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82127-00482127-004-01, 82127-004-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
BUTYLPHENYL METHYLPROPIONALT7540GJV69IACT
CITRALT7EU0O9VPPIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
COUMARINA4VZ22K1WTIACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT
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
0daab837-6092-b472-e063-6394a90a360feef49bc3-a75c-4168-9cb3-4f533ea2ab452023-12-29WarningsExact identifier
spl id: 0daab837-6092-b472-e063-6394a90a360f
spl set id: eef49bc3-a75c-4168-9cb3-4f533ea2ab45

Reported adverse events (FAERS/openFDA)#

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