FDA.reportPublic FDA data

Antibacterial

Manufacturer
Safetec of America | Safetec of America, Inc.
Effective date
2011-05-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:51:31

Label at a glance#

ProductAntibacterial
Active ingredientalcohol
Label structure8 sections

Indications and uses

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

Dosage and administration

tear open packet, remove towelette wet hand/wrist area for 15 seconds and discard supervise children under 6 years of age

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 when soap and water is not available

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 or redness develop and persist 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

  • tear open packet, remove towelette
  • wet hand/wrist area for 15 seconds and discard
  • supervise children under 6 years of age

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe vera, fragrance, purified water, triethanolamine

SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215
800-456-7077

PRINCIPAL DISPLAY PANEL – Anti-Bacterial Hand Wipe Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-3112-0

Just for you®

ANTI-BACTERIAL HAND WIPE

Cleans and Sanitizes Hands

Use Before Each Meal

One [1] Wipe

PRINCIPAL DISPLAY PANEL – Anti-Bacterial Hand Wipe Label
PRINCIPAL DISPLAY PANEL – Anti-Bacterial Hand Wipe Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61010-3112-02021-01-26C16284748780-19d75b9d0-b4e8-f424-e053-dadaa90a57ceJust for you ® ANTI-BACTERIAL HAND WIPE
61010-3112-02020-01-31C16284748780-19d75b9d0-b4e8-f424-e053-dadaa90a57ceJust for you ® ANTI-BACTERIAL HAND WIPE

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
61010-311261010-3112-0

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
alcohol3K9958V90MACTIB
aloeV5VD430YW9IACT
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
trolamineTROLAMINE9O3K93S3TKCREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL, METERED / TOPICAL20 mgExact 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
trolamineTROLAMINE9O3K93S3TKGEL / TRANSDERMAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL, METERED / TRANSDERMAL14 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOAP / TOPICAL0.08 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKDROPS / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKPOWDER / TOPICAL0.02 mg/mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 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
trolamineTROLAMINE9O3K93S3TKSHAMPOO / TOPICAL3.7 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, FOAM / VAGINAL2 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSPONGE / TOPICAL11 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSPRAY / NASALNAExact 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
fb08b795-03a3-444b-b882-3433dbf76db5c7c00a29-77e2-43fc-bf2e-014046edd5e12020-12-30WarningsExact identifier
spl set id: c7c00a29-77e2-43fc-bf2e-014046edd5e1

Reported adverse events (FAERS/openFDA)#

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