FDA.reportPublic FDA data

Hand Sanitizer Gel

Manufacturer
Broder Bros Prime Line
Effective date
2020-10-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:09:39

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

for hand sanitizing.

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Uses

INDICATIONS & USAGE SECTION

for hand sanitizing.

Warnings

WARNINGS SECTION

Flammable, keep away from fire 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

Stop use and ask a doctor if irritation and redness develops and persists for more than 72 hours.

Keep our of reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or call a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

  • Store at 66 to 77 F (22 to 25 C)
  • May discolor some fabrics
  • Harmful to wood finishes and platics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Glycerin, Triethanolamine, Water

Questions?

OTC - QUESTIONS SECTION

1-800-873-7746

M-F 8am-5pm EST

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5 mL NDC: 80017-003-01

Hand Sanitizer

Net wt. 5mL/0.17 fl.oz.

PDPPDP

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80017-00380017-003-01
74742-009

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT

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
bcd89935-bf71-26f5-e053-2a95a90a26bcb2c9b78c-39bd-eb09-e053-2a95a90ad7cd2021-03-06WarningsExact identifier
spl set id: b2c9b78c-39bd-eb09-e053-2a95a90ad7cd

Reported adverse events (FAERS/openFDA)#

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