FDA.reportPublic FDA data

Instant Hand Sanitizer

Manufacturer
Safetec of America, Inc. | Safetec of America, Inc
Effective date
2015-02-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:30:53

Label at a glance#

ProductInstant Hand Sanitizer
Active ingredientalcohol
Label structure9 sections

Indications and uses

for handwashing to decrease bacteria on skin whenever soap and water handwashing is not readily available helps prevent the risk of cross-contamination of bacteria that potentially can cause disease or infection recommended for repeated use

Dosage and administration

place a small amount into one hand spread over both hands and wrist rub into the skin until dry do not wipe off; no rinsing required

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • for handwashing to decrease bacteria on skin whenever soap and water handwashing is not readily available
  • helps prevent the risk of cross-contamination of bacteria that potentially can cause disease or infection
  • recommended for repeated use

Warnings

WARNINGS SECTION

For external use only. Flammable, keep away from fire or flame

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes. If contact occurs, rinse eyes thoroughly with water

Stop use and ask doctor if

OTC - STOP USE SECTION

  • 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 swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • place a small amount into one hand
  • spread over both hands and wrist
  • rub into the skin until dry
  • do not wipe off; no rinsing required

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, carbomer, red dye, fragrance, purified water, triethanolamine

Principal Display Panel - Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-8111-0

Safetec

instant
Hand
Sanitizer

Kills 99.9% of Germs

Enriched with
Aloe Vera

Apple

34,688 fl.oz. (1,026 L) Reorder No. 17394

Manufactured by SAFETEC OF AMERICA, Inc. Buffalo, NY 14215 800-456-7077 www.safetec.com

Principal Display Panel - Container Label
Principal Display Panel - Container Label

Principal Display Panel - Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-8111-1

Safetec

instant
Hand
Sanitizer

KILLS 99.9% OF GERMS

ENRICHED WITH ALOE VERA

NATIONAL
BREAST
CANCER
FOUNDATION, INC®.

APPLE SCENT

4.0 FL. OZ. (118 ML)

Principal Display Panel - Container Label
Principal Display Panel - Container Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
alcoholACTIVE INGREDIENT3K9958V90M2
alcoholACTIVE MOIETY3K9958V90M2
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X2
carbomer interpolymer type a (allyl sucrose crosslinked)INACTIVE INGREDIENT59TL3WG5CO2
trolamineINACTIVE INGREDIENT9O3K93S3TK2
waterINACTIVE INGREDIENT059QF0KO0R2

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
61010-811161010-8111-0, 61010-8111-1

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

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
trolamineTROLAMINE9O3K93S3TKAEROSOL, FOAM / VAGINAL2 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL, METERED / TRANSDERMAL14 mgExact 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
trolamineTROLAMINE9O3K93S3TKDROPS / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact 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
trolamineTROLAMINE9O3K93S3TKINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL, METERED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL / TRANSDERMAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSHAMPOO / TOPICAL3.7 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSPRAY / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOAP / TOPICAL0.08 %w/wExact 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
a250e0cd-6b05-491d-b729-528580583394bfc82054-8b24-430c-b57b-2e4895faac482019-12-06WarningsExact identifier
spl set id: bfc82054-8b24-430c-b57b-2e4895faac48

Reported adverse events (FAERS/openFDA)#

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