FDA.reportPublic FDA data

OPALINE Hand Sanitizer

Manufacturer
Ganzhou Olivee Cosmetic Co., Ltd.
Effective date
2020-04-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:06:25

Label at a glance#

ProductOPALINE Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% w/w

Purpose

OTC - PURPOSE SECTION

 Antiseptic

Use

INDICATIONS & USAGE SECTION

Decrease bacteria on hands.

Warnings

WARNINGS SECTION

For external use only.

Flammable.Keep product away from fire or flame.

When using this product

avoid contact with eyes; in case of contact, flush eyes with water.

Stop use and ask a doctor if

irritation or redness develops and persists.

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.

Small Parts. Not for children under 3 years.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Glycerin

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130692962190389GTIN-13: 0692962190389
EAN-13: 0692962190389
GTIN-12: 692962190389
UPC-A: 692962190389
GTIN storage (14 digits): 00692962190389		opaline hand sanitizer 2 sizes of 250 500 ml 70.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
56136-302-012025-01-30C16284748780-12cef2736-5e3a-d83d-e063-dadaa90ab31fOPALINE HAND SANITIZER
56136-302-022025-01-30C16284748780-12cef2736-5e3a-d83d-e063-dadaa90ab31fOPALINE HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56136-302-01OPALINE Hand Sanitizer250 mL in 1 BOTTLEGEL2501
56136-302-02OPALINE Hand Sanitizer500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56136-302OPALINE HAND SANITIZER (ALCOHOL) GEL [GANZHOU OLIVEE COSMETIC CO., LTD.]1Legacy NDC, 2 package rows20200416_9c870994-0310-46b6-bdb5-fb84342e6343.zip

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
56136-30256136-302-01, 56136-302-02

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
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT

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
1daf894c-43b8-40b8-b0eb-f42aeee7dba29c870994-0310-46b6-bdb5-fb84342e63432020-04-16WarningsExact identifier
spl id: 1daf894c-43b8-40b8-b0eb-f42aeee7dba2
spl set id: 9c870994-0310-46b6-bdb5-fb84342e6343

Reported adverse events (FAERS/openFDA)#

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