FDA.reportPublic FDA data

Instant Hand Sanitizer

Product NDC
61010-1112
Requested package NDC
61010-1112-3
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

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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL665 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
616762Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c3f0556d-f967-4f19-922c-57a2bf184892Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
61010-1112-42026-01-149d75b9d0-0d36-f424-e053-dadaa90a57ceSafetec Instant Hand Sanitizer
61010-1112-72026-01-149d75b9d0-0d36-f424-e053-dadaa90a57ceSafetec Instant Hand Sanitizer
61010-1112-22024-02-16d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-32024-02-16d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-82024-02-16d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-02024-02-139d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-52024-02-139d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-62024-02-139d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-02024-01-309d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-22024-01-30d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-32024-01-30d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-52024-01-309d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-62024-01-309d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-82024-01-30d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-02022-03-019d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-22022-03-01d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-32022-03-01d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-52022-03-019d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-62022-03-019d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-82022-03-01d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-02022-01-289d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-22022-01-28d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-32022-01-28d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-52022-01-289d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-62022-01-289d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-82022-01-28d6a99b39-8859-a426-e053-dadaa90af4c261010-1112-2,-3,-8, Instant Hand Sanitzer
61010-1112-52020-02-039d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-62020-02-039d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-42020-01-319d75b9d0-0d36-f424-e053-dadaa90a57ceSafetec Instant Hand Sanitizer
61010-1112-52020-01-319d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-62020-01-319d75b9d0-6b62-f424-e053-dadaa90a57ce61010-1112, Instant Hand Sanitizer
61010-1112-72020-01-319d75b9d0-0d36-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

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 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9a9fc7c-31da-ea3f-e053-2a95a90a0eab2026-09-09WarningsExact identifier
application number: M003
Alcohol Prep Pad MediumALCOHOL PREP PADYangzhou Huanrui Medical Technology Co., Ltd5af3eedc-d01e-c9e9-e063-6394a90a49e12026-09-08WarningsExact identifier
application number: M003
Henry Schein Povidone-Iodine Prep PadPOVIDONE-IODINEHenry Schein, Inc.313416b8-60b2-4a77-9b56-5c507aae90722026-09-08WarningsExact identifier
application number: M003
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5af9f31b-0c92-e3a9-e063-6394a90a38c92026-09-08WarningsExact identifier
application number: M003
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5afc0201-490e-ccf3-e063-6394a90aadad2026-09-08WarningsExact identifier
application number: M003
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57ccc28b-5f5f-30ec-e063-6294a90a081c2026-09-07WarningsExact identifier
application number: M003
hand sanitizer - cherry sundaeALCOHOLGanzhou Olivee Cosmetic Co., Ltd.270d2ce0-6310-4a84-be8a-72db6062bae72026-09-07WarningsExact identifier
application number: M003
hand sanitizer - vanilla frostingALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f6cabda2-6e1c-4238-9a2e-df10e263517d2026-09-07WarningsExact identifier
application number: M003
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ba3612b3-9696-417a-ba66-eb9dc5ea27c62026-09-07WarningsExact identifier
application number: M003
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.5b0ac694-66e0-437f-86cd-09f259344b892026-09-07WarningsExact identifier
application number: M003
Sweethearts - Crush On You - Peach SkinALCOHOLScent Theory Products LLC5ac32582-d888-edf4-e063-6394a90a40ab2026-09-05WarningsExact identifier
application number: M003
Sweethearts - Be Mine - Sugared BerriesALCOHOLScent Theory Products LLC5ac32ffb-926a-f249-e063-6394a90a8d872026-09-05WarningsExact identifier
application number: M003
Sweethearts - UR Sweet - Sweet Cherry Hand SanitizerALCOHOLScent Theory Products LLC5ac33b21-9192-8baa-e063-6294a90a6e752026-09-05WarningsExact identifier
application number: M003
Sweethearts - Ooo La La - Banana Cream Hand SanitizerALCOHOLScent Theory Products LLC5ac34dda-fbdf-0ca7-e063-6394a90ab7642026-09-05WarningsExact identifier
application number: M003
SurviveX PREP WIPESALCOHOL PREP PADChangzhou Maokang Medical Products Co., Ltd.5a7e9dc6-cf43-7ffc-e063-6394a90a3faa2026-09-04WarningsExact identifier
application number: M003
Members MarkISOPROPYL ALCOHOLSams West Incc251ac50-f74f-4a48-e053-2a95a90aac0d2026-09-04WarningsExact identifier
application number: M003
WalmartISOPROPYL ALCOHOLWalmart, Inc.2f1342ef-1843-40a6-e063-6294a90a577f2026-09-04WarningsExact identifier
application number: M003
Curad Alcohol Prep Pads MediumISOPROPYL ALCOHOLMedline Industries, LP1ce3872e-2307-4a38-bd7d-7eb2b226cf3c2026-09-04WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLSuperValu, Inc.5e6e6d6f-4472-40f1-b0a9-96cee7ef075b2026-09-04WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLFoodhold U.S.A. LLCa94c023c-5313-4940-90a7-b3061a8b90e12026-09-04WarningsExact identifier
application number: M003

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
61010-1112-361010111203144 POUCH in 1 BOX (61010-1112-3) / .034 L in 1 POUCH (61010-1112-1) 144 pouch2010-12-150000-00-00NoNoCurrent