FDA.reportPublic FDA data

Skininc

Manufacturer
Skininc Global Pte. Ltd.
Effective date
2020-10-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:31

Label at a glance#

ProductSkininc
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease.  For use when soap and water are not available.

Dosage and administration

Place enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Denatured Ethyl Alcohol 65% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial.

Warnings

WARNINGS SECTION

  • Flammable. Keep away from fire or flame.
  • For external use only.
  • When using this product do not use it in or near eyes. In case of contact, rinse eyes thoroughly with water.
  • Stop use and ask a doctor if irritation or rash appears and lasts.
  • Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

  • Hand Sanitizer to help reduce bacteria that potentially can cause disease. 
  • For use when soap and water are not available.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product.

Other Information 

SPL UNCLASSIFIED SECTION

  • Store below 1100F(430C)
  • May discolour certain fabrics.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Water,Mannitol,Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Aminomethyl Propanol,Microcrystalline Cellulose,PEG-20 Sorbitan Cocoate,Carbomer,Disodium EDTA,Butylene Glycol,1,2-Hexanediol,Mentha Rotundifolia Leaf Extract,Mentha Piperita (Peppermint) Leaf Extract,Mentha Aquatica Leaf Extract,Cucurbita Pepo (Pumpkin) Fruit Extract,Perilla Frutescens Extract,Rheum Palmatum Root Extract,Angelica Gigas Extract,Cnidium Officinale Root Extract,Melaleuca Alternifolia (Tea Tree) Leaf Extract, Fragrance

Product Image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN1
902574ethanol 0.65 ML/ML Topical GelSCD1
902574ethyl alcohol 65 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80761-001-012022-01-28C16284748780-1d6a99b39-4932-a426-e053-dadaa90af4c2SKININC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80761-001-01Skininc15 mL in 1 BOTTLEGEL151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80761-001SKININC (ALCOHOL) GEL [SKININC GLOBAL PTE. LTD.]1Legacy NDC, 1 package rows20201014_24b65720-fb5c-4d9d-a9c1-e07383fcc23e.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80761-00180761-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
MANNITOL3OWL53L36AIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
MAGNESIUM DISODIUM EDTANDT563S5VZIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
MENTHA X ROTUNDIFOLIA LEAFK59TXG2L3UIACT
MENTHA X PIPERITA WHOLE79M2M2UDA9IACT
MENTHA AQUATICA LEAF5M106ME6PTIACT
PUMPKINSYW0QUB89YIACT
RHEUM PALMATUM ROOTG025DAL7CEIACT
ANGELICA GIGAS ROOT32766B2FHXIACT
CNIDIUM OFFICINALE ROOT8S3OZD358JIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT

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
e1d41368-c726-4139-9648-cd9793211ced24b65720-fb5c-4d9d-a9c1-e07383fcc23e2020-10-07WarningsExact identifier
spl id: e1d41368-c726-4139-9648-cd9793211ced
spl set id: 24b65720-fb5c-4d9d-a9c1-e07383fcc23e

Reported adverse events (FAERS/openFDA)#

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