FDA.reportPublic FDA data

RAINBOW HAND SANITIZER PURPLE

Manufacturer
Belleson Inc
Effective date
2021-10-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:44:23

Label at a glance#

ProductRAINBOW HAND SANITIZER PURPLE
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. Warnings For external use only, Flammable. Keep away from heat or flame

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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and
water are not available. Warnings For external use only, Flammable. Keep away from heat or flame

Warnings

WARNINGS SECTION

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.

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

SPL UNCLASSIFIED SECTION

  • Store between 15-30C (59-86F)

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Aloe vera leaf , Carbomer, Triethanolamine, Mugwort extract, Calendula officinalis flower, Camellia Sinensis Leaf Extract, Mulberry root extract, Licorice extract, Rosmarinus officinalis (Rosmary) leaf oil, Polysorbate 20, Fragrance, FD&C BLUE NO. 1, D&C RED NO. 33

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75063-0014-12022-07-29C16284748780-1e4f33bdf-a675-d8a0-e053-dadaa90a6e4e97766dad-2ff1-4964-bec1-e06dd48a9bea

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75063-0014-1RAINBOW HAND SANITIZER PURPLE500 mL in 1 BOTTLE, PLASTICGEL5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75063-0014RAINBOW HAND SANITIZER PURPLE (ETHYL ALCOHOL) GEL [BELLESON INC]2Legacy NDC, 1 package rows20211023_97766dad-2ff1-4964-bec1-e06dd48a9bea.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75063-001475063-0014-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
MORUS ALBA ROOTCST1G9BZGDIACT
POLYSORBATE 207T1F30V5YHIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CAMELLIA SINENSIS ROOT8H54O0V2K3IACT
LICORICE61ZBX54883IACT
ROSEMARYIJ67X351P9IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT
ARTEMISIA PRINCEPS LEAFSY077EW02GIACT
ALCOHOL3K9958V90MACTIB

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
cef54e19-91e2-f1f4-e053-2995a90a1ccb97766dad-2ff1-4964-bec1-e06dd48a9bea2021-10-22WarningsExact identifier
spl id: cef54e19-91e2-f1f4-e053-2995a90a1ccb
spl set id: 97766dad-2ff1-4964-bec1-e06dd48a9bea

Reported adverse events (FAERS/openFDA)#

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