FDA.reportPublic FDA data

Instant Hand Sanitizer

Manufacturer
Safetec of America, Inc.
Effective date
2013-05-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:24:15

Label at a glance#

ProductInstant Hand Sanitizer
Active ingredientalcohol
Label structure8 sections

Indications and uses

for handwashing to decrease bacteria on skin without soap and water recommended for repeated use

Dosage and administration

wet hands and wrists thoroughly with product allow to dry without wiping children under 6 should be supervised while using this product

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 66.5%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • for handwashing to decrease bacteria on skin without soap and water
  • recommended for repeated use

Warnings

WARNINGS SECTION

For external use only.

Flammable, keep away from fire or flame

OTC - DO NOT USE SECTION

Do not use in the eyes. If this happens, rinse thoroughly with water

OTC - STOP USE SECTION

Stop use and ask doctor if irritation and redness develop and persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children If ingested get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • wet hands and wrists thoroughly with product
  • allow to dry without wiping
  • children under 6 should be supervised while using this product

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, carbomer, fragrance, purified water, triethanolamine

Principal Display Panel – 16 Fl. OZ. Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-2111-4

Safetec

Instant
Hand
Sanitizer

A.B.H.C. ™ MEETS CDC HANDWASHING RECOMMENDATIONS

Kills 99.9% of Germs

Enriched with
Aloe Vera

Citrus

16 FL. OZ. (473 ML)

Reorder No. 18354

Principal Display Panel – 16 Fl. OZ. Bottle Label
Principal Display Panel – 16 Fl. OZ. Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61010-2111-12022-01-28C16284748780-19d75b9d0-2fa4-f424-e053-dadaa90a57ceA.B.H.C. INSTANT HAND SANITIZER CITRUS SCENT (alcohol) gel [Safetec of America, Inc.]
61010-2111-42022-01-28C16284748780-19d75b9d0-2fa4-f424-e053-dadaa90a57ceA.B.H.C. INSTANT HAND SANITIZER CITRUS SCENT (alcohol) gel [Safetec of America, Inc.]
61010-2111-72022-01-28C16284748780-19d75b9d0-2fa4-f424-e053-dadaa90a57ceA.B.H.C. INSTANT HAND SANITIZER CITRUS SCENT (alcohol) gel [Safetec of America, Inc.]
61010-2111-72020-08-10C16284748780-19d75b9d0-2fa4-f424-e053-dadaa90a57ceA.B.H.C. INSTANT HAND SANITIZER CITRUS SCENT (alcohol) gel [Safetec of America, Inc.]
61010-2111-72020-01-31C16284748780-19d75b9d0-2fa4-f424-e053-dadaa90a57ceA.B.H.C. INSTANT HAND SANITIZER CITRUS SCENT (alcohol) gel [Safetec of America, Inc.]

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-2111-1Instant Hand Sanitizer0.118 L in 1 BOTTLEGEL0.1182
61010-2111-4Instant Hand Sanitizer0.473 L in 1 BOTTLEGEL0.4732
61010-2111-7Instant Hand Sanitizer1.9 L in 1 BOTTLEGEL1.92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-2111INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]2Legacy NDC, 3 package rows20200811_691462b7-d118-4018-8985-5e32f38146d9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
alcoholACTIVE INGREDIENT3K9958V90M1
alcoholACTIVE MOIETY3K9958V90M1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X1
carbomer interpolymer type a (55000 mpa.s)INACTIVE INGREDIENT59TL3WG5CO1
trolamineINACTIVE INGREDIENT9O3K93S3TK1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61010-211161010-2111-1, 61010-2111-4, 61010-2111-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
alcohol3K9958V90MACTIB
aloe vera leafZY81Z83H0XIACT
carbomer interpolymer type a (allyl sucrose crosslinked)59TL3WG5COIACT
water059QF0KO0RIACT
trolamine9O3K93S3TKIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
trolamineTROLAMINE9O3K93S3TKGEL / TRANSDERMAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL, METERED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKPOWDER / TOPICAL0.02 mg/mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSPONGE / TOPICAL11 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKDROPS / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSPRAY / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL, METERED / TRANSDERMAL14 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, FOAM / VAGINAL2 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOAP / TOPICAL0.08 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSHAMPOO / TOPICAL3.7 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates

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
2e61d674-cb19-44fa-a13f-a2f0fdb4ad7c691462b7-d118-4018-8985-5e32f38146d92013-05-17WarningsExact identifier
spl id: 2e61d674-cb19-44fa-a13f-a2f0fdb4ad7c
spl set id: 691462b7-d118-4018-8985-5e32f38146d9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.