FDA.reportPublic FDA data

Instant Hand Sanitizer

Product NDC
61010-1112
11-digit product format
610101112
Labeler code
61010
Product ID
61010-1112_4884e33b-faea-970e-e063-6394a90a6b1d
Type
HUMAN OTC DRUG
Nonproprietary name
alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Safetec of America, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-03-22
Substance
ALCOHOL
Active strength
665 mL/L
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Instant Hand Sanitizer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL665 mL/L

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui616762

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61010-1112-42026-01-14C16284748780-19d75b9d0-0d36-f424-e053-dadaa90a57ceSafetec Instant Hand Sanitizer
61010-1112-72026-01-14C16284748780-19d75b9d0-0d36-f424-e053-dadaa90a57ceSafetec Instant Hand Sanitizer
61010-1112-22024-02-16C16284748780-1d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-32024-02-16C16284748780-1d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-82024-02-16C16284748780-1d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-02024-02-13C16284748780-19d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-52024-02-13C16284748780-19d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-62024-02-13C16284748780-19d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-02024-01-30C16284748780-19d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-22024-01-30C16284748780-1d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-32024-01-30C16284748780-1d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-52024-01-30C16284748780-19d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-62024-01-30C16284748780-19d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-82024-01-30C16284748780-1d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-02022-03-01C16284748780-19d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-22022-03-01C16284748780-1d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-32022-03-01C16284748780-1d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-52022-03-01C16284748780-19d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-62022-03-01C16284748780-19d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-82022-03-01C16284748780-1d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-02022-01-28C16284748780-19d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-22022-01-28C16284748780-1d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-32022-01-28C16284748780-1d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-52022-01-28C16284748780-19d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-62022-01-28C16284748780-19d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-82022-01-28C16284748780-1d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-52020-02-03C16284748780-19d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-62020-02-03C16284748780-19d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-42020-01-31C16284748780-19d75b9d0-0d36-f424-e053-dadaa90a57ceSafetec Instant Hand Sanitizer
61010-1112-52020-01-31C16284748780-19d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-62020-01-31C16284748780-19d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-72020-01-31C16284748780-19d75b9d0-0d36-f424-e053-dadaa90a57ceSafetec Instant Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-1112-1Instant Hand Sanitizer0.034 L in 1 POUCHGEL0.0349
61010-1112-2Instant Hand Sanitizer25 in 1 BOXGEL259
61010-1112-3Instant Hand Sanitizer144 in 1 BOXGEL1449
61010-1112-8Instant Hand Sanitizer10 in 1 BOXGEL109
61010-1112-0Instant Hand Sanitizer0.046 L in 1 BOTTLEGEL0.0466
61010-1112-5Instant Hand Sanitizer0.118 L in 1 BOTTLEGEL0.1186
61010-1112-6Instant Hand Sanitizer0.237 L in 1 BOTTLE, PUMPGEL0.2376
61010-1112-4Instant Hand Sanitizer1026 L in 1 CONTAINERGEL10264
61010-1112-7Instant Hand Sanitizer208.2 L in 1 CONTAINERGEL208.24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
alcoholACTIVE INGREDIENT3K9958V90MINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA]3
alcoholACTIVE MOIETY3K9958V90MINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA]3
aloeINACTIVE INGREDIENTV5VD430YW9INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA]3
trolamineINACTIVE INGREDIENT9O3K93S3TKINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA]3
waterINACTIVE INGREDIENT059QF0KO0RINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA]3
alcoholACTIVE INGREDIENT3K9958V90MINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA]2
alcoholACTIVE MOIETY3K9958V90MINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA]2
aloeINACTIVE INGREDIENTV5VD430YW9INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA]2
trolamineINACTIVE INGREDIENT9O3K93S3TKINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA]2
waterINACTIVE INGREDIENT059QF0KO0RINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA]2
alcoholACTIVE INGREDIENT3K9958V90MINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]1
alcoholACTIVE MOIETY3K9958V90MINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]1
D&C GREEN NO. 5INACTIVE INGREDIENT8J6RDU8L9XINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]1
d&c yellow no. 10INACTIVE INGREDIENT35SW5USQ3GINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]1
trolamineINACTIVE INGREDIENT9O3K93S3TKINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-1112INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA]7Current NDC, Legacy NDC, 4 package rows20240217_3b5b46d0-308a-4649-8384-246da3a18ba1.zip
61010-1112INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]4Current NDC, Legacy NDC, 3 package rows20240214_c3f0556d-f967-4f19-922c-57a2bf184892.zip
61010-1112CARE SCIENCE OSHA FIRST AID (ETHYL ALCOHOL, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, DIPHENHYDRAMINE HYDROCHLORIDE, HYDROCORTISONE, IBUPROFEN, ACETAMINOPHEN, WATER) KIT [ASO LLC]2Current NDC, Legacy NDC20241107_1cbace4d-fd0a-41d1-aa71-907d43620bf8.zip
61010-1112INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA]2Current NDC, Legacy NDC, 2 package rows20141020_bf69cc74-ebe9-40c3-a95a-a489492cc693.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616762ethanol 66.5 % Topical GelPSN3b5b46d0-308a-4649-8384-246da3a18ba19
616762ethanol 0.665 ML/ML Topical GelSCD3b5b46d0-308a-4649-8384-246da3a18ba19
616762ethanol 66.5 % Topical GelSY3b5b46d0-308a-4649-8384-246da3a18ba19
616762ethanol 66.5 % Topical GelPSNc3f0556d-f967-4f19-922c-57a2bf1848926
616762ethanol 0.665 ML/ML Topical GelSCDc3f0556d-f967-4f19-922c-57a2bf1848926
616762ethanol 66.5 % Topical GelSYc3f0556d-f967-4f19-922c-57a2bf1848926
616762ethanol 66.5 % Topical GelPSNbf69cc74-ebe9-40c3-a95a-a489492cc6934
616762ethanol 0.665 ML/ML Topical GelSCDbf69cc74-ebe9-40c3-a95a-a489492cc6934
616762ethanol 66.5 % Topical GelSYbf69cc74-ebe9-40c3-a95a-a489492cc6934
616762ethanol 66.5 % Topical GelPSNc94e8db3-2db7-fce4-e053-2a95a90a62d93
616762ethanol 0.665 ML/ML Topical GelSCDc94e8db3-2db7-fce4-e053-2a95a90a62d93
616762ethanol 66.5 % Topical GelSYc94e8db3-2db7-fce4-e053-2a95a90a62d93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61010-1112-061010111200.046 L in 1 BOTTLE (61010-1112-0) 2012-03-220000-00-00NoNoCurrent
61010-1112-1610101112010.034 L in 1 POUCH0.034 lHistorical
61010-1112-26101011120225 POUCH in 1 BOX (61010-1112-2) / .034 L in 1 POUCH (61010-1112-1) 25 pouch2010-12-150000-00-00NoNoCurrent
61010-1112-361010111203144 POUCH in 1 BOX (61010-1112-3) / .034 L in 1 POUCH (61010-1112-1) 144 pouch2010-12-150000-00-00NoNoCurrent
61010-1112-4610101112041026 L in 1 CONTAINER (61010-1112-4) 1026 l2010-12-16NoNoHistorical
61010-1112-561010111205.118 L in 1 BOTTLE (61010-1112-5) 2012-03-220000-00-00NoNoCurrent
61010-1112-661010111206.237 L in 1 BOTTLE, PUMP (61010-1112-6) 2012-03-220000-00-00NoNoCurrent
61010-1112-761010111207208.2 L in 1 CONTAINER (61010-1112-7) 208.2 l2014-10-14NoNoHistorical
61010-1112-86101011120810 POUCH in 1 BOX (61010-1112-8) / .034 L in 1 POUCH (61010-1112-1) 10 pouch2020-04-010000-00-00NoNoCurrent