FDA.reportPublic FDA data

Instant Hand Sanitizer

Product NDC
61010-1111
11-digit product format
610101111
Labeler code
61010
Product ID
61010-1111_1134d900-005e-bd65-e063-6294a90a63f4
Type
HUMAN OTC DRUG
Nonproprietary name
alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Safetec of America, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-12-16
Substance
ALCOHOL
Active strength
540.26 g/L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL540.26 g/L

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61010-1111-02024-02-12C16284748780-11030e365-24b6-111a-e063-dadaa90a10e261010-111, Instant Hand Sanitizer
61010-1111-12024-02-12C16284748780-11030e365-24b6-111a-e063-dadaa90a10e261010-111, Instant Hand Sanitizer
61010-1111-32024-02-12C16284748780-11030e365-24b6-111a-e063-dadaa90a10e261010-111, Instant Hand Sanitizer
61010-1111-42024-02-12C16284748780-11030e365-24b6-111a-e063-dadaa90a10e261010-111, Instant Hand Sanitizer
61010-1111-52024-02-12C16284748780-11030e365-24b6-111a-e063-dadaa90a10e261010-111, Instant Hand Sanitizer
61010-1111-62024-02-12C16284748780-11030e365-24b6-111a-e063-dadaa90a10e261010-111, Instant Hand Sanitizer
61010-1111-72024-02-12C16284748780-11030e365-24b6-111a-e063-dadaa90a10e261010-111, Instant Hand Sanitizer
61010-1111-82024-02-12C16284748780-11030e365-24b6-111a-e063-dadaa90a10e261010-111, Instant Hand Sanitizer
61010-1111-92024-02-12C16284748780-11030e365-24b6-111a-e063-dadaa90a10e261010-111, Instant Hand Sanitizer
61010-1111-02024-01-30C16284748780-11030e365-24b6-111a-e063-dadaa90a10e261010-111, Instant Hand Sanitizer
61010-1111-12024-01-30C16284748780-11030e365-24b6-111a-e063-dadaa90a10e261010-111, Instant Hand Sanitizer
61010-1111-32024-01-30C16284748780-11030e365-24b6-111a-e063-dadaa90a10e261010-111, Instant Hand Sanitizer
61010-1111-42024-01-30C16284748780-11030e365-24b6-111a-e063-dadaa90a10e261010-111, Instant Hand Sanitizer
61010-1111-52024-01-30C16284748780-11030e365-24b6-111a-e063-dadaa90a10e261010-111, Instant Hand Sanitizer
61010-1111-62024-01-30C16284748780-11030e365-24b6-111a-e063-dadaa90a10e261010-111, Instant Hand Sanitizer
61010-1111-72024-01-30C16284748780-11030e365-24b6-111a-e063-dadaa90a10e261010-111, Instant Hand Sanitizer
61010-1111-82024-01-30C16284748780-11030e365-24b6-111a-e063-dadaa90a10e261010-111, Instant Hand Sanitizer
61010-1111-92024-01-30C16284748780-11030e365-24b6-111a-e063-dadaa90a10e261010-111, Instant Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-1111-0Instant Hand Sanitizer0.059 L in 1 BOTTLEGEL0.0596
61010-1111-1Instant Hand Sanitizer0.118 L in 1 BOTTLEGEL0.1186
61010-1111-3Instant Hand Sanitizer100 in 1 BOXGEL1006
61010-1111-3Instant Hand Sanitizer0.0037 L in 1 PACKETGEL0.00376
61010-1111-4Instant Hand Sanitizer0.473 L in 1 BOTTLEGEL0.4736
61010-1111-5Instant Hand Sanitizer0.8 L in 1 BOXGEL0.86
61010-1111-6Instant Hand Sanitizer0.237 L in 1 BOTTLEGEL0.2376
61010-1111-7Instant Hand Sanitizer1.9 L in 1 BOTTLEGEL1.96
61010-1111-8Instant Hand Sanitizer100 in 1 BOXGEL1006
61010-1111-8Instant Hand Sanitizer0.00168 L in 1 PACKETGEL0.001686
61010-1111-9Instant Hand Sanitizer1 L in 1 BOXGEL16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
alcoholACTIVE INGREDIENT3K9958V90MINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]3
alcoholACTIVE MOIETY3K9958V90MINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]3
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]3
carbomer interpolymer type a (55000 mpa.s)INACTIVE INGREDIENT59TL3WG5COINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]3
d&c green no. 5INACTIVE INGREDIENT8J6RDU8L9XINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]3
d&c yellow no. 10INACTIVE INGREDIENT35SW5USQ3GINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]3
trolamineINACTIVE INGREDIENT9O3K93S3TKINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]3
waterINACTIVE INGREDIENT059QF0KO0RINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-1111INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]6Current NDC, Legacy NDC, 11 package rows20240214_016f9770-3dd5-4480-a687-f9bb2ea73e86.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61010-1111-061010111100.059 L in 1 BOTTLE (61010-1111-0) 2010-12-160000-00-00NoNoCurrent
61010-1111-161010111101.118 L in 1 BOTTLE (61010-1111-1) 2010-12-160000-00-00NoNoCurrent
61010-1111-361010111103100 PACKET in 1 BOX (61010-1111-3) / .0037 L in 1 PACKET100 packet2010-12-160000-00-00NoNoCurrent
61010-1111-461010111104.473 L in 1 BOTTLE (61010-1111-4) 2010-12-160000-00-00NoNoCurrent
61010-1111-561010111105.8 L in 1 BOX (61010-1111-5) 2010-12-160000-00-00NoNoCurrent
61010-1111-661010111106.237 L in 1 BOTTLE (61010-1111-6) 2010-12-160000-00-00NoNoCurrent
61010-1111-7610101111071.9 L in 1 BOTTLE (61010-1111-7) 1.9 l2010-12-160000-00-00NoNoCurrent
61010-1111-861010111108100 PACKET in 1 BOX (61010-1111-8) / .00168 L in 1 PACKET100 packet2010-12-160000-00-00NoNoCurrent
61010-1111-9610101111091 L in 1 BOX (61010-1111-9) 1 l2010-12-160000-00-00NoNoCurrent