FDA.reportPublic FDA data

Antimicrobial

Manufacturer
Safetec of America, Inc.
Effective date
2024-02-05
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:08:18

Label at a glance#

ProductAntimicrobial
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

for handwashing to decrease bacteria on skin whenever soap and water is not readily available

Dosage and administration

wet hands and wrists thoroughly for 15 seconds and allow to air dry always reseal after use children under 6 years of age should be supervised when 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 whenever soap and water is not readily available

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

Stop use and ask doctor if

OTC - STOP USE SECTION

  • irritation or 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

  • wet hands and wrists thoroughly for 15 seconds and allow to air dry
  • always reseal after use
  • children under 6 years of age should be supervised when using this product

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe vera, fragrance, purified water, triethanolamine

SAFETEC OF AMERICA, Inc.
887 Kensington Ave. Buffalo, NY 14215
800-456-7077 www.safetec.com

Reorder no. 34409

275 Gal. (1,041 L)

PRINCIPAL DISPLAY PANEL – 275 Gallon Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-3111-4

Safetec

p.a.w.s.

Antimicrobial

Liquid

  • Kills 99.9% of Germs!
  • Contains 66.5% Ethyl Alcohol
  • Enriched with Aloe Vera

Fresh Scent

Drug Facts

Active Ingredient Purpose

Ethyl Alcohol 66.5% Antiseptic

Uses

  • for handwashing to decrease bacteria on skin whenever soap and water is not readily available

Warnings

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

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

Stop use and ask doctor if

  • irritation or redness develop and persists for more than 72 hours

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

Directions

  • wet hands and wrists thoroughly for 15 seconds and allow to air dry
  • always reseal after use
  • children under 6 years of age should be supervised when using this product

Inactive ingredients

Aloe vera, fragrance, purified water, triethanolamine

SAFETEC OF AMERICA, Inc.

887 Kensington Ave. Buffalo, NY 14215

800-456-7077 www.safetec.com

Reorder no. 34409

275 Gal. (1,041 L)

PRINCIPAL DISPLAY PANEL – 275 Gallon Container Label
PRINCIPAL DISPLAY PANEL – 275 Gallon Container Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1087912ethanol 66.5 % Topical SolutionPSN6
1087912ethanol 0.665 ML/ML Topical SolutionSCD6
1087912ethanol 66.5 % Topical SolutionSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61010-3111-12024-02-05C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws
61010-3111-22024-02-05C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws
61010-3111-32024-02-05C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws
61010-3111-42024-02-05C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws
61010-3111-12024-01-30C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws
61010-3111-22024-01-30C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws
61010-3111-32024-01-30C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws
61010-3111-42024-01-30C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws
61010-3111-12022-03-01C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws
61010-3111-22022-03-01C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws
61010-3111-32022-03-01C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws
61010-3111-42022-03-01C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws
61010-3111-52022-03-01C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws
61010-3111-62022-03-01C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws
61010-3111-12022-01-28C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws
61010-3111-22022-01-28C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws
61010-3111-32022-01-28C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws
61010-3111-42022-01-28C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws
61010-3111-52022-01-28C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws
61010-3111-62022-01-28C16284748780-1d6a99b39-d7ae-a426-e053-dadaa90af4c2Antimicrobial Liquid Paws

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-3111-1Antimicrobial0.0019 L in 1 PACKETLIQUID0.00196
61010-3111-1Antimicrobial100 in 1 BOXLIQUID1006
61010-3111-2Antimicrobial0.224 L in 1 CANISTERLIQUID0.2246
61010-3111-3Antimicrobial0.58 L in 1 CANISTERLIQUID0.586
61010-3111-4Antimicrobial1041 L in 1 CONTAINERLIQUID10416

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-3111ANTIMICROBIAL (ALCOHOL) LIQUID [SAFETEC OF AMERICA, INC.]6Current NDC, Legacy NDC, 5 package rows20240206_4a070d45-f7fd-4eab-a2ba-48445d54fe5d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
alcoholACTIVE INGREDIENT3K9958V90M2
alcoholACTIVE MOIETY3K9958V90M2
aloeINACTIVE INGREDIENTV5VD430YW92
trolamineINACTIVE INGREDIENT9O3K93S3TK2
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61010-311161010-3111-4, 61010-3111-1, 61010-3111-2, 61010-3111-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9IACT
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 · 5 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
trolamineTROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii+route+dosage form
5 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii+route+dosage form
5 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii+route+dosage form
5 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii+route+dosage form
5 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii+route+dosage form
5 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
AntimicrobialALCOHOLSafetec of America, Inc.4a070d45-f7fd-4eab-a2ba-48445d54fe5d2024-02-05WarningsExact identifier
ndc (package): 61010-3111-1
ndc (package): 61010-3111-2
ndc (package): 61010-3111-3
ndc (package): 61010-3111-4
ndc (product): 61010-3111
ndc11 (package): 61010311104
ndc11 (package): 61010311103
ndc11 (package): 61010311101
ndc11 (package): 61010311102
spl id: 10a9bfb1-8910-734f-e063-6294a90a20d7
spl set id: 4a070d45-f7fd-4eab-a2ba-48445d54fe5d

Reported adverse events (FAERS/openFDA)#

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