FDA.reportPublic FDA data

U.S COLOURS

Manufacturer
East-B Corp.
Effective date
2020-05-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:15:14

Label at a glance#

ProductU.S COLOURS
Active ingredientALCOHOL
Label structure9 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

▪  Store between 15-30°C (59-86°F) ▪  Avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 72% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

▪  in children less than 2 months of age

▪  on open skin wounds

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. 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

▪  Store between 15-30°C (59-86°F)

▪  Avoid freezing and excessive heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients water, glycerin, acrylates/vinyl isodecanoate crosspolmer, aminomethyl propanol, fragrance, panthenol, aloe barbadensis leaf juice, tocopherol acetate

SPL UNCLASSIFIED SECTION

DESINFECTANTE DE MANOS

✓  Wash Free

✓  Antibacterial Activity

✓  Disinfection

✓  Clean

DIST. BY: EAST-B CORPORATION, LOS ANGELES, USA.

DESIGNED IN NEWYORK U.S.A.

MADE IN CHINA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052530ethanol 72 % Topical SolutionPSN3
1052530ethanol 0.72 ML/ML Topical SolutionSCD3
1052530ethanol 72 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74655-555-022022-01-28C16284748780-1d6a99b39-c0de-a426-e053-dadaa90af4c2U.S COLOURS ADVANCED HAND SANITIZER
74655-555-032022-01-28C16284748780-1d6a99b39-c0de-a426-e053-dadaa90af4c2U.S COLOURS ADVANCED HAND SANITIZER
74655-555-102022-01-28C16284748780-1d6a99b39-c0de-a426-e053-dadaa90af4c2U.S COLOURS ADVANCED HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74655-555-02U.S COLOURS70 mL in 1 BOTTLE, PLASTICLIQUID703
74655-555-03U.S COLOURS60 mL in 1 BOTTLE, PLASTICLIQUID603
74655-555-10U.S COLOURS310 mL in 1 BOTTLE, PLASTICLIQUID3103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74655-555U.S COLOURS (ALCOHOL) LIQUID [EAST-B CORP.]3Legacy NDC, 3 package rows20200529_d79af114-ce66-48b3-94a4-52c5d97e733f.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74655-55574655-555-10, 74655-555-02, 74655-555-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
PANTHENOLWV9CM0O67ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
baaefc74-463d-4394-925d-856847b226f6d79af114-ce66-48b3-94a4-52c5d97e733f2020-05-22WarningsExact identifier
spl id: baaefc74-463d-4394-925d-856847b226f6
spl set id: d79af114-ce66-48b3-94a4-52c5d97e733f

Reported adverse events (FAERS/openFDA)#

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