FDA.reportPublic FDA data

Antibacterial Hand Sanitizer

Manufacturer
Broder Bros Co.
Effective date
2025-11-17
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:30:32

Label at a glance#

ProductAntibacterial Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

For hand sanitizing

Dosage and administration

Wet hands thoroughly with product, briskly rub together until dry Always supervise children in the use of this product Children under 6 months of age: ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For hand sanitizing

Warnings

WARNINGS SECTION

Flammable. Keep away from heat and flame.

For external use only

When using this product

OTC - WHEN USING SECTION

  • Keep out of eyes
  • In case of contact with eyes, flush thoroughly with water
  • Avoid contact with broken skin
  • Do not inhale or ingest

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation and redness develops and persists for more than 72 hours

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help promptly and contact Poison Control

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product, briskly rub together until dry
  • Always supervise children in the use of this product
  • Children under 6 months of age: ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

Store at 20° C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, fragrance, glycerin, propylene glycol, tocopheryl acetate, triethanolamine, water

Questions?

OTC - QUESTIONS SECTION

1-800-873-7746 M-F 8am - 5pm EST

SPL UNCLASSIFIED SECTION

0.5 oz / 15 ml

Dist. By: Broder Bros. Co., dba Prime Line

Gaffney, SC 29341

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

front panelfront panel

drug facts paneldrug facts panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN5
581660ethanol 0.62 ML/ML Topical GelSCD5
581660ethanol 62 % Topical GelSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71513-105-01Antibacterial Hand Sanitizer29.57 mL in 1 BOTTLEGEL29.575
71513-105-03Antibacterial Hand Sanitizer59.12 mL in 1 BOTTLEGEL59.125
71513-105-04Antibacterial Hand Sanitizer236.59 mL in 1 BOTTLEGEL236.595
71513-105-05Antibacterial Hand Sanitizer473.18 mL in 1 BOTTLEGEL473.185
71513-105-06Antibacterial Hand Sanitizer14.79 mL in 1 BOTTLEGEL14.795
71513-105-50Antibacterial Hand Sanitizer29.57 mL in 1 TUBEGEL29.575

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71513-10571513-105-01, 71513-105-03, 71513-105-04, 71513-105-05, 71513-105-06, 71513-105-50

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
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

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 SanitizerETHYL ALCOHOLBroder Bros Co.b8183dae-4cdc-c369-e053-2995a90a75c42025-11-17WarningsExact identifier
ndc (package): 71513-105-03
ndc (package): 71513-105-01
ndc (package): 71513-105-05
ndc (package): 71513-105-50
ndc (package): 71513-105-04
ndc (package): 71513-105-06
ndc (product): 71513-105
ndc11 (package): 71513010506
ndc11 (package): 71513010550
ndc11 (package): 71513010504
ndc11 (package): 71513010505
ndc11 (package): 71513010501
ndc11 (package): 71513010503
spl id: 43d13e36-df5e-eee2-e063-6394a90a60cf
spl set id: b8183dae-4cdc-c369-e053-2995a90a75c4

Reported adverse events (FAERS/openFDA)#

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