INSTANT HAND SANITIZER (alcohol) gel [Safetec of America]

Manufacturer
Safetec of America, Inc.
Effective date
2013-05-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:40:47

Label at a glance#

ProductInstant Hand Sanitizer
Active ingredientalcohol
Label structure9 sections

Indications and uses

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

Dosage and administration

wet hands & 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, ask a doctor if irritation and redness develop and persists for 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 & 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, D&C green # 5, D&C yellow # 10, fragrance, purified water, triethanolamine

PRINCIPAL DISPLAY PANEL – 0.0570 fl. oz. box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-1111-8

Safetec

instant

Hand

Sanitizer

Kills 99.9% of Germs
Enriched with Aloe Vera

Fresh Scent

0.0570 FL. OZ. (1.68 ML) packets
100 packets per box

Reorder No. 17353

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

PRINCIPAL DISPLAY PANEL – 0.0570 fl. oz. box
PRINCIPAL DISPLAY PANEL – 0.0570 fl. oz. box

PRINCIPAL DISPLAY PANEL – 0.0570 fl. oz. packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-1111-8

Safetec

instant

Hand

Sanitizer

Fresh Scent

0.0570 fl.oz.
(1.68 ML)

Reorder No. 17353

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

PRINCIPAL DISPLAY PANEL – 0.0570 fl. oz. packet
PRINCIPAL DISPLAY PANEL – 0.0570 fl. oz. packet

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
d&c green no. 5INACTIVE INGREDIENT8J6RDU8L9X1
d&c yellow no. 10INACTIVE INGREDIENT35SW5USQ3G1
trolamineINACTIVE INGREDIENT9O3K93S3TK1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61010-111161010-1111-3, 61010-1111-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
trolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
d&c yellow no. 10D&C YELLOW NO. 1035SW5USQ3GGEL / TOPICALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
d&c green no. 5D&C GREEN NO. 58J6RDU8L9XSHAMPOO / TOPICAL0.09 %w/wExact identifier — unii+route
6 equally ranked IID candidates
d&c green no. 5D&C GREEN NO. 58J6RDU8L9XSHAMPOO / TOPICAL0.09 %w/wExact identifier — unii+route
6 equally ranked IID candidates
d&c yellow no. 10D&C YELLOW NO. 1035SW5USQ3GGEL / TOPICALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
d&c green no. 5D&C GREEN NO. 58J6RDU8L9XSOAP / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
d&c green no. 5D&C GREEN NO. 58J6RDU8L9XSHAMPOO / TOPICAL0.09 %w/wExact identifier — unii+route
6 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
d&c green no. 5D&C GREEN NO. 58J6RDU8L9XSOAP / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
d&c yellow no. 10D&C YELLOW NO. 1035SW5USQ3GGEL / TOPICALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
d&c green no. 5D&C GREEN NO. 58J6RDU8L9XSOAP / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
3 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 · 2 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): 61010-1111-3
ndc (package): 61010-1111-8
ndc (product): 61010-1111
ndc11 (package): 61010111108
ndc11 (package): 61010111103
982a523e-247d-4bc5-87ff-1bd89df2dac376834261-76eb-4e72-aba9-89a19b1974102013-05-17WarningsExact identifier
spl id: 982a523e-247d-4bc5-87ff-1bd89df2dac3
spl set id: 76834261-76eb-4e72-aba9-89a19b197410

Reported adverse events (FAERS/openFDA)#

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