FDA.reportPublic FDA data

Santi-Gel Instant Hand Sanitizer

Product NDC
50865-056
11-digit product format
508650056
Labeler code
50865
Product ID
50865-056_298e35b0-1ab3-212b-e063-6394a90a787e
Type
HUMAN OTC DRUG
Nonproprietary name
Santi-Gel Instant Hand Sanitizer
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Kutol Products Company, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-05-22
Substance
ALCOHOL
Active strength
62.5 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Santi-Gel Instant Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL62.5 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50865-056-03Santi-Gel Instant Hand Sanitizer208175 mL in 1 DRUMSOLUTION20817513
50865-056-07Santi-Gel Instant Hand Sanitizer3875 mL in 1 BOTTLESOLUTION387513
50865-056-12Santi-Gel Instant Hand Sanitizer1200 mL in 1 BAGSOLUTION120013
50865-056-19Santi-Gel Instant Hand Sanitizer236 mL in 1 BOTTLE, PLASTICSOLUTION23613
50865-056-30Santi-Gel Instant Hand Sanitizer473 mL in 1 BOTTLE, PLASTICSOLUTION47313
50865-056-34Santi-Gel Instant Hand Sanitizer118 mL in 1 BOTTLE, PLASTICSOLUTION11813
50865-056-35Santi-Gel Instant Hand Sanitizer118 mL in 1 BOTTLE, PLASTICSOLUTION11813
50865-056-36Santi-Gel Instant Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICSOLUTION100013
50865-056-38Santi-Gel Instant Hand Sanitizer800 mL in 1 BAGSOLUTION80013
50865-056-43Santi-Gel Instant Hand Sanitizer236 mL in 1 BOTTLESOLUTION23613
50865-056-65Santi-Gel Instant Hand Sanitizer800 mL in 1 BAGSOLUTION80013
50865-056-66Santi-Gel Instant Hand Sanitizer800 mL in 1 BAGSOLUTION80013
50865-056-67Santi-Gel Instant Hand Sanitizer2000 mL in 1 BOTTLESOLUTION200013
50865-056-79Santi-Gel Instant Hand Sanitizer1892 mL in 1 BOTTLE, PUMPSOLUTION189213
50865-056-82Santi-Gel Instant Hand Sanitizer800 mL in 1 BOTTLESOLUTION80013
50865-056-86Santi-Gel Instant Hand Sanitizer800 mL in 1 BAGSOLUTION80013
50865-056-93Santi-Gel Instant Hand Sanitizer1200 mL in 1 BOTTLE, PLASTICSOLUTION120013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MSANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
ALCOHOLACTIVE MOIETY3K9958V90MSANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8SANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626QSANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSSANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
POLYACRYLIC ACID (250000 MW)INACTIVE INGREDIENT9G2MAD7J6WSANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50865-056SANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.]13Current NDC, Legacy NDC, 17 package rows20241220_f5bb2593-e036-4586-a807-2049e06b2475.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50865-056-0350865005603208175 mL in 1 DRUM (50865-056-03) 208175 ml2015-05-150000-00-00NoNoCurrent
50865-056-07508650056073875 mL in 1 BOTTLE (50865-056-07) 3875 ml2019-01-010000-00-00NoNoCurrent
50865-056-12508650056121200 mL in 1 BAG1200 mlHistorical
50865-056-1950865005619236 mL in 1 BOTTLE, PLASTIC (50865-056-19) 236 ml2013-05-220000-00-00NoNoCurrent
50865-056-3050865005630473 mL in 1 BOTTLE, PLASTIC (50865-056-30) 473 ml2013-05-220000-00-00NoNoCurrent
50865-056-3450865005634118 mL in 1 BOTTLE, PLASTIC (50865-056-34) 118 ml2013-05-220000-00-00NoNoCurrent
50865-056-3550865005635118 mL in 1 BOTTLE, PLASTIC (50865-056-35) 118 ml2013-05-220000-00-00NoNoCurrent
50865-056-36508650056361000 mL in 1 BOTTLE, PLASTIC (50865-056-36) 1000 ml2013-05-220000-00-00NoNoCurrent
50865-056-3850865005638800 mL in 1 BAG (50865-056-38) 800 ml2017-05-100000-00-00NoNoCurrent
50865-056-4350865005643236 mL in 1 BOTTLE (50865-056-43) 236 ml2020-01-010000-00-00NoNoCurrent
50865-056-6550865005665800 mL in 1 BAG800 mlHistorical
50865-056-6650865005666800 mL in 1 BAG (50865-056-66) 800 ml2017-05-100000-00-00NoNoCurrent
50865-056-67508650056672000 mL in 1 BOTTLE (50865-056-67) 2000 ml2019-01-010000-00-00NoNoCurrent
50865-056-79508650056791892 mL in 1 BOTTLE, PUMP (50865-056-79) 1892 ml2013-05-220000-00-00NoNoCurrent
50865-056-8250865005682800 mL in 1 BOTTLE800 mlHistorical
50865-056-8650865005686800 mL in 1 BAG800 mlHistorical
50865-056-93508650056931200 mL in 1 BOTTLE, PLASTIC1200 mlHistorical