Instant Hand Sanitizer

Product NDC
61010-1111
Requested package NDC
61010-1111-7
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

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL540.26 g/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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
016f9770-3dd5-4480-a687-f9bb2ea73e86Available on FDA.report

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#

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
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 interpolymer type a (55000 mpa.s)INACTIVE INGREDIENT59TL3WG5COINSTANT 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
61010-1111INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]6Current NDC, Legacy NDC, 11 package rows20240214_016f9770-3dd5-4480-a687-f9bb2ea73e86.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 SanitizerALCOHOLSafetec of America, Inc.016f9770-3dd5-4480-a687-f9bb2ea73e862024-02-12WarningsExact identifier
ndc (package): 61010-1111-7
ndc (product): 61010-1111
ndc11 (package): 61010111107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61010-1111-7610101111071.9 L in 1 BOTTLE (61010-1111-7) 1.9 l2010-12-160000-00-00NoNoCurrent