Instant Hand Sanitizer KE-53SAN

Product NDC
64121-693
11-digit product format
641210693
Labeler code
64121
Product ID
64121-693_289cddc1-a937-5cae-e063-6294a90a499a
Type
HUMAN OTC DRUG
Nonproprietary name
Instant Hand Sanitizer KE-53SAN
Dosage form
LIQUID
Route
TOPICAL
Labeler
Kinzua Environmental
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-23
Substance
ALCOHOL
Active strength
67 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Instant Hand Sanitizer KE-53SAN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL67 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9a829a7-851a-3811-e053-2a95a90a2b90Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64121-693-02Instant Hand Sanitizer KE-53SAN236 mL in 1 BOTTLE, PLASTICLIQUID2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64121-693INSTANT HAND SANITIZER KE-53SAN LIQUID [KINZUA ENVIRONMENTAL]2Current NDC, Legacy NDC, 1 package rows20241208_d9a829a7-851a-3811-e053-2a95a90a2b90.zip

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
Instant Hand Sanitizer KE-53SANINSTANT HAND SANITIZER KE-53SANKinzua Environmentald9a829a7-851a-3811-e053-2a95a90a2b902024-12-06WarningsExact identifier
ndc (product): 64121-693

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64121-693-0264121069302236 mL in 1 BOTTLE, PLASTIC (64121-693-02) 236 ml2022-02-230000-00-00NoNoCurrent