FDA.reportPublic FDA data

Justice Vanilla Scented Anti-bacterial Hand Sanitizer

Product NDC
60637-227
11-digit product format
606370227
Labeler code
60637
Product ID
60637-227_08996332-bbf4-0192-e063-6294a90a4692
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
TWEEN BRANDS, INC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-20
Substance
ALCOHOL
Active strength
620 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Justice Vanilla Scented Anti-bacterial Hand SanitizerALCOHOLTWEEN BRANDS, INC0d61d7a1-f222-4799-a632-87d0a95627132023-10-26WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Flammable, keep away from fire or flame. For external use only. Do not use in the eyes the eyes or apply the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal 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 Irritation persists for more than 72 hours. Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Justice Vanilla Scented Anti-bacterial Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL620 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581660

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60637-227-30Justice Vanilla Scented Anti-bacterial Hand Sanitizer30 mL in 1 BOTTLEGEL305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60637-227JUSTICE VANILLA SCENTED ANTI-BACTERIAL HAND SANITIZER (ALCOHOL) GEL [TWEEN BRANDS, INC]5Current NDC, Legacy NDC, 1 package rows20231026_0d61d7a1-f222-4799-a632-87d0a9562713.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN0d61d7a1-f222-4799-a632-87d0a95627135
581660ethanol 0.62 ML/ML Topical GelSCD0d61d7a1-f222-4799-a632-87d0a95627135
581660ethanol 62 % Topical GelSY0d61d7a1-f222-4799-a632-87d0a95627135

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60637-227-306063702273030 mL in 1 BOTTLE (60637-227-30) 30 ml2019-04-200000-00-00NoNoCurrent