Hand Sanitizer

Manufacturer
Jefferson Labs
Effective date
2020-08-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:19:22

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

to help reduce bacteria on the skin that could cause disease recommended for repeated use

Dosage and administration

For 946 mL bottle use to refill a pump bottle. From the pump bottle apply a small amount onto hands, rub thoroughly with product and allow to dry without wiping do not use on children less than 2 months of age not recommended for infants For 473 mL bottle wet hands thoroughly with product and allow to dry without wiping do not use on children less than 2 months of age not recommended for infants

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • to help reduce bacteria on the skin that could cause disease
  • recommended for repeated use

Warnings

WARNINGS SECTION

For external use only: hands

Flammable. Keep away from fire or flame.

When using this product 

  • 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 if

  • irritation and redness develops
  • condition 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

For 946 mL bottle

  • use to refill a pump bottle. From the pump bottle apply a small amount onto hands, rub thoroughly with product and allow to dry without wiping
  • do not use on children less than 2 months of age
  • not recommended for infants

For 473 mL bottle

  • wet hands thoroughly with product and allow to dry without wiping
  • do not use on children less than 2 months of age
  • not recommended for infants

Other Information

OTHER SAFETY INFORMATION

  • store between 20–25° C (68–77° F). Avoid excessive heat above 40° C (104° F).
  • may discolor some fabrics
  • harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citrate Buffer, Glycerin, Hydroxyethyl Cellulose, Isopropyl Alcohol, PEG, Water

SPL UNCLASSIFIED SECTION

image descriptionimage description

MANUFACTURED BY:
Aurora Pharmaceutical, Inc.
NORTHFIELD, MINNESOTA 55057
888-215-1256

MADE IN THE USA

image descriptionimage description

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51072-112-00

PRO-TEC®

Hand Sanitizer

70% Ethyl Alcohol

REFILL

32 fl. oz. (946 mL)

REORDER NO: 21025

IN 50-1661 02/2020

image descriptionimage description

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51072-112-01

PRO-TEC®

Hand Sanitizer

70% Ethyl Alcohol

16 fl. oz. (473 mL)

REORDER NO: 21026

IN 50-1663 02/2020

image descriptionimage description

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
51072-11251072-112-00, 51072-112-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
e645a4c4-abbb-4117-ba51-0d1d2cecd46b53739cfe-1b29-4e3d-95bf-ba1569413d3a2020-08-04WarningsExact identifier
spl id: e645a4c4-abbb-4117-ba51-0d1d2cecd46b
spl set id: 53739cfe-1b29-4e3d-95bf-ba1569413d3a

Reported adverse events (FAERS/openFDA)#

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