FDA.reportPublic FDA data

MODAKA

Manufacturer
WE LABS COMPANY LIMITED
Effective date
2020-05-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:44

Label at a glance#

ProductMODAKA HAND SANITIZER
Active ingredientALCOHOL
Label structure7 sections

Label contents#

Full prescribing information#

Active Ingredient (s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Anti-Bacterial, Anti-microbial and Germs

INDICATIONS & USAGE SECTION

Use(s) for hand-washing to decrease bacteria on the skin, only when water is not available

Warnings

WARNINGS SECTION

Flammable, keep away from fire and flames

For external use only

When using this product

- do not get into eyes

- if contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if

- irritation and redness develop

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Direction No water required. Apply to hands, rub in, ensuring contact with fingernails and in between fingers. Can also be applied to the body.

INACTIVE INGREDIENT SECTION

Inactive Ingredients water, Propylene Glycol, Trehalose, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Benzoate, Potasssium Sorbate, Triethanolamine, Dendrobium Bigibbum Flower, Calendula Officinalis (Marigold) Flower Extract, Fragrance, Allantoin.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77779-002-012022-01-28C16284748780-1d6a99b39-3f93-a426-e053-dadaa90af4c2modaka Hand Sanitizer
77779-002-022022-01-28C16284748780-1d6a99b39-3f93-a426-e053-dadaa90af4c2modaka Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77779-002-01MODAKAHAND SANITIZER60 mL in 1 TUBEGEL601
77779-002-02MODAKAHAND SANITIZER450 mL in 1 BOTTLE, PUMPGEL4501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77779-002MODAKA HAND SANITIZER (ETHYL ALCOHOL) GEL [WE LABS COMPANY LIMITED]1Legacy NDC, 2 package rows20200603_99c04ee7-ac58-412b-aabc-aef4673c1bfe.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77779-00277779-002-01, 77779-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TREHALOSEB8WCK70T7IIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
TROLAMINE9O3K93S3TKIACT
DENDROBIUM BIGIBBUM FLOWERQ7KU1V305FIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ALLANTOIN344S277G0ZIACT

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
79b17b85-9923-4a5b-8893-d02af1972a4299c04ee7-ac58-412b-aabc-aef4673c1bfe2020-05-15WarningsExact identifier
spl id: 79b17b85-9923-4a5b-8893-d02af1972a42
spl set id: 99c04ee7-ac58-412b-aabc-aef4673c1bfe

Reported adverse events (FAERS/openFDA)#

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