FDA.reportPublic FDA data

Antibacterial Hand Sanitizer

Manufacturer
TEKWELD SOLUTIONS, INC.
Effective date
2024-02-05
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:08:20

Label at a glance#

ProductAntibacterial Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

For hand washing to decrease bacteria on the skin.

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses:

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin.

Warnings:

WARNINGS SECTION

Flammable.Keep away from fire or flame. For external use only.

When using this product

OTC - WHEN USING SECTION

Keep out of eyes. In case of contact with eyes, rinse with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation and redness develops and persists.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help promptly and contact Poison Control Center.

Directions:

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry without wiping.

Other Information:

SPL UNCLASSIFIED SECTION

Store under 105°F.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

Package Labeling:71160-189-05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

Package Labeling:71160-189-10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label02Label02

Package Labeling: 70412-189-20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 20Label 20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020364ethanol 62 % Topical SprayPSN8
1020364ethanol 0.62 ML/ML Topical SpraySCD8
1020364ethanol 62 % Topical SpraySY8
1020364ethyl alcohol 62 % Topical SpraySY8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71160-189-05Antibacterial Hand Sanitizer5 mL in 1 BOTTLESPRAY58
71160-189-10Antibacterial Hand Sanitizer10 mL in 1 BOTTLESPRAY108
71160-189-20Antibacterial Hand Sanitizer20 mL in 1 BOTTLESPRAY208
71160-189-25Antibacterial Hand Sanitizer25 mL in 1 BOTTLESPRAY258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71160-189ANTIBACTERIAL HAND SANITIZER (ALCOHOL) SPRAY [TEKWELD SOLUTIONS, INC.]8Current NDC, Legacy NDC, 4 package rows20240207_45af86a4-a413-0309-e054-00144ff88e88.zip

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
71160-18971160-189-10, 71160-189-05, 71160-189-25, 71160-189-20

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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML · Source PDF

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
Antibacterial Hand SanitizerALCOHOLTEKWELD SOLUTIONS, INC.45af86a4-a413-0309-e054-00144ff88e882024-02-05WarningsExact identifier
ndc (package): 71160-189-10
ndc (package): 71160-189-25
ndc (package): 71160-189-20
ndc (package): 71160-189-05
ndc (product): 71160-189
ndc11 (package): 71160018925
ndc11 (package): 71160018905
ndc11 (package): 71160018920
ndc11 (package): 71160018910
spl id: 10ab6d24-091c-0407-e063-6394a90a5d6b
spl set id: 45af86a4-a413-0309-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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