FDA.reportPublic FDA data

NDC 61010-4111-1, Instant Hand Sanitizer-alcohol gel

Manufacturer
Safetec of America, Inc.
Effective date
2024-03-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:09:14

Label at a glance#

ProductInstant Hand Sanitizer
Active ingredientALCOHOL
Label structure8 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, D&C green #5, D&C yellow#10, fragrance, purified water, triethanolamine

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 34,688 fl. oz. Container Label

NDC 61010-4111-1

Safetec

instant

Hand

Sanitizer

Kills 99.9% of Germs

Enriched with

Aloe Vera

Fresh

34,688 fl.oz. (1,026 L) Reorder No. 17392

PRINCIPAL DISPLAY PANEL – 34,688 fl. oz. Container Label
PRINCIPAL DISPLAY PANEL – 34,688 fl. oz. Container Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN4
581662ethanol 0.7 ML/ML Topical GelSCD4
581662ethanol 70 % Topical GelSY4
581662ethyl alcohol 70 % Topical GelSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61010-4111-12022-04-06C16284748780-19d75b9d0-8a4f-f424-e053-dadaa90a57ceNDC 61010-4111-1, Instant Hand Sanitizer-alcohol gel
61010-4111-12020-01-31C16284748780-19d75b9d0-8a4f-f424-e053-dadaa90a57ceNDC 61010-4111-1, Instant Hand Sanitizer-alcohol gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-4111-1Instant Hand Sanitizer1026000 mL in 1 CONTAINERGEL10260004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-4111INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]4Current NDC, Legacy NDC, 1 package rows20240302_0f6f2a67-4fed-407e-a2c5-51574a5bbf65.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
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
61010-411161010-4111-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
D&C GREEN NO. 58J6RDU8L9XIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB

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 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
trolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
d&c green no. 5D&C GREEN NO. 58J6RDU8L9XSOAP / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
d&c yellow no. 10D&C YELLOW NO. 1035SW5USQ3GGEL / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
d&c green no. 5D&C GREEN NO. 58J6RDU8L9XSHAMPOO / TOPICAL0.09 %w/wExact identifier — unii+route
4 equally ranked IID candidates
d&c yellow no. 10D&C YELLOW NO. 1035SW5USQ3GGEL / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
d&c green no. 5D&C GREEN NO. 58J6RDU8L9XSOAP / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
d&c green no. 5D&C GREEN NO. 58J6RDU8L9XSHAMPOO / TOPICAL0.09 %w/wExact identifier — unii+route
4 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
2 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
Instant Hand SanitizerALCOHOLSafetec of America, Inc.0f6f2a67-4fed-407e-a2c5-51574a5bbf652024-03-01WarningsExact identifier
ndc (package): 61010-4111-1
ndc (product): 61010-4111
ndc11 (package): 61010411101
spl id: 129de921-3817-daaf-e063-6394a90a7b9c
spl set id: 0f6f2a67-4fed-407e-a2c5-51574a5bbf65

Reported adverse events (FAERS/openFDA)#

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