FDA.reportPublic FDA data

Justice Diamond Vanilla Scented Antibacterial Hand Sanitizer

Manufacturer
Tween Brands,Inc.
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:57:46

Label at a glance#

ProductJustice Diamond Vanilla Scented Antibacterial Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping Supervise children in the use of this product.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • for hand-washing to decrease bacteria on the skin, 
  • Recommended for repeated area

Warnings

WARNINGS SECTION

Flammable, keep away from fire or flames

For external use only

Do not use

OTC - DO NOT USE SECTION

in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animals bites, or serious burns, consult a doctor. Use only as directed.  Do not drink. If taken internally, it will produce serious gastric disturbances.


Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Irritation persists for more than 72 hours.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wet hands thoroughly with product and allow to dry without wiping
  • Supervise children in the use of this product.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Propylene Glycol, Fragrance, Carbomer, Aminomethyl Propanol, Mica, Red 40.

Other information

SPL UNCLASSIFIED SECTION

  • Store below 105°F (40.5°C).
  • May discolor some fabrics: Expiry Date 10/2022

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN4
581660ethanol 0.62 ML/ML Topical GelSCD4
581660ethanol 62 % Topical GelSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60637-194-30Justice Diamond Vanilla Scented Antibacterial Hand Sanitizer30 mL in 1 BOTTLEGEL304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60637-194JUSTICE DIAMOND VANILLA SCENTED ANTIBACTERIAL HAND SANITIZER (ALCOHOL) GEL [TWEEN BRANDS,INC.]4Current NDC, Legacy NDC, 1 package rows20231026_9bcba4da-d3e8-d4c2-e053-2a95a90a432f.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60637-19460637-194-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
MICAV8A1AW0880IACT
FD&C RED NO. 40WZB9127XOAIACT
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
Justice Diamond Vanilla Scented Antibacterial Hand SanitizerALCOHOLTween Brands,Inc.9bcba4da-d3e8-d4c2-e053-2a95a90a432f2023-10-26WarningsExact identifier
ndc (package): 60637-194-30
ndc (product): 60637-194
ndc11 (package): 60637019430
spl id: 089948f1-8e9f-3775-e063-6294a90a05e2
spl set id: 9bcba4da-d3e8-d4c2-e053-2a95a90a432f

Reported adverse events (FAERS/openFDA)#

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