FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
VANILLA SUGAR PTY LTD | Mirfeel Korea
Effective date
2020-04-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:07:36

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Avoid freezing and store below above 40ºC (104ºF) May discolor some fabrics or surfaces

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70%. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin that potentially can cause disease.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Avoid freezing and store below above 40ºC (104ºF)
  • May discolor some fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Carbomer, Triethanolamine, Honey Extract, Menthol, Cymbopogon Citratus (Lemongrass) Extract, Anthemis Nobilis (Chamomile) Flower Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

150 mL NDC: 74443-010-15 150 mL Label150 mL Label

500 mL NDC: 74443-010-50 500 mL Label500 mL Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74443-010-152022-01-28C16284748780-1d6a99b39-bde8-a426-e053-dadaa90af4c2a242cf7a-8549-6b1f-e053-2995a90a2459
74443-010-502022-01-28C16284748780-1d6a99b39-bde8-a426-e053-dadaa90af4c2a242cf7a-8549-6b1f-e053-2995a90a2459

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74443-010-15Hand Sanitizer150 mL in 1 BOTTLEGEL1501
74443-010-50Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74443-010HAND SANITIZER (ALCOHOL) GEL [VANILLA SUGAR PTY LTD]1Legacy NDC, 2 package rows20200424_a242cf7a-8549-6b1f-e053-2995a90a2459.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74443-01074443-010-15, 74443-010-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
CARBOMER 934Z135WT9208IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CYMBOPOGON CITRATUS WHOLE6AE8LT94NGIACT
HONEYY9H1V576FHIACT
CHAMOMILEFGL3685T2XIACT
MENTHOLL7T10EIP3AIACT

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
a242bc59-73f9-d753-e053-2995a90aa5d5a242cf7a-8549-6b1f-e053-2995a90a24592020-04-01WarningsExact identifier
spl id: a242bc59-73f9-d753-e053-2995a90aa5d5
spl set id: a242cf7a-8549-6b1f-e053-2995a90a2459

Reported adverse events (FAERS/openFDA)#

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