FDA.reportPublic FDA data

Pro-Source

Manufacturer
Inopak, Ltd
Effective date
2019-10-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:03:34

Label at a glance#

ProductPro-Source Distributors
Active ingredientalcohol
Label structure11 sections

Indications and uses

For handwashing to decrease bacteria on the skin after changing diapers, assisting ill persons, or before contact with a person under medical care or treatment. Recommended for repeated use.

Dosage and administration

If hands are visibly soiled, was with soap and water and dry hands. Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic   

Uses

INDICATIONS & USAGE SECTION

  • For handwashing to decrease bacteria on the skin after changing diapers, assisting ill persons, or before contact with a person under medical care or treatment.
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

  • For external use only. Keep out of eyes, ears, or mouth.
  • Discontinue use if irritation occurs.
  • Keep out of reach of children.

FLAMMABLE, KEEP AWA FROM FIRE OR FLAME

When using

OTC - WHEN USING SECTION

  • Keep out of eyes, ears, or mouth.
  • Discontinue use if irritation occurs.

Stop Use

OTC - STOP USE SECTION

  • Discontinue use if irritation occurs.

Keep away from children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • If hands are visibly soiled, was with soap and water and dry hands.
  • Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing.

Inactive ingredient

INACTIVE INGREDIENT SECTION

benzalkonium chloride, chlorhexidine gluconate, isopropyl alcohol, PEG 10 dimethicone, PEG-14M, phenoxyethanol, polyquaternium 10, water.

Pro-Source PDI Individual label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pro-Source                                                                                         PDI-9605              Rev.1.0

Distributors                                                                                                        PDI-9605

Your Professional Source for Janitorial Supplies                                                    1000mL

PDI Instant Alcohol Hand Sanitizer

MADE                   Compliant with CDC Hand Hygiene Guidelines                       Active:

IN THE                   Kills more than 99.99% of germs in 15 seconds                   Ethyl Alcohol 70%

USA                       Does not contain DEA/MEA, triclosan, parabens, formaldehyde, dyes, fragrance

Drug Facts

Active Ingredient                                             Purpose

Ethyl Alcohol 70% v/v……………………………Antiseptic

Uses

  • For handwashing to decrease bacteria on the skin after changing diapers, assisting ill persons, or before contact with a person under medical care or treatment.
  • Recommended for repeated use.

Warnings

  • For external use only. Keep out of eyes, ears, or mouth.
  • Discontinue use if irritation occurs.
  • Keep out of reach of children.

FLAMMABLE, KEEP AWA FROM FIRE OR FLAME.

Directions

  • If hands are visibly soiled, was with soap and water and dry hands.
  • Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing.

Inactive Ingredients benzalkonium chloride, chlorhexidine gluconate, isopropyl alcohol, PEG 10 dimethicone, PEG-14M, phenoxyethanol, polyquaternium 10, water.

Pro-Source Distributors, Inc.        815-229-9555 • www.pdisupply.com

Pro-Source Individual labelPro-Source Individual label

Pro-Source Case label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pro-Source

Distributors

Your Professional Source for Janitorial Supplies 

PDI Instant Alcohol Hand Sanitizer

Compliant with CDC Hand Hygiene Guidelines   

Kills more than 99.99% of germs in 15 seconds  

Does not contain DEA/MEA, triclosan, parabens, formaldehyde, dyes, fragrance

Sold By: Pro-Source Distributors, Inc.

2613 – 11th Street, Rockford, IL  61109

815-229-9555

www.pdi1supply.com

Active:

Ethyl Alcohol 70%

Net Contents:

6/1000 mL BAGS

Drug Facts

Active Ingredient                                             Purpose

Ethyl Alcohol 70% v/v……………………………Antiseptic

Uses

  • For handwashing to decrease bacteria on the skin after changing diapers, assisting ill persons, or before contact with a person under medical care or treatment.
  • Recommended for repeated use.

Warnings

  • For external use only. Keep out of eyes, ears, or mouth.
  • Discontinue use if irritation occurs.
  • Keep out of reach of children.

FLAMMABLE, KEEP AWA FROM FIRE OR FLAME.

Directions

  • If hands are visibly soiled, was with soap and water and dry hands.
  • Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing.

Inactive Ingredients benzalkonium chloride, chlorhexidine gluconate, isopropyl alcohol, PEG 10 dimethicone, PEG-14M, phenoxyethanol, polyquaternium 10, water.

PDI-9605-CS  Rev.1.0   PDI-9605

Pro-Source Case labelPro-Source Case label

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58575-20158575-201-01, 58575-201-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
alcohol3K9958V90MACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
ISOPROPYL ALCOHOLND2M416302IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
PEG-14 1-((METHYLPHENYL)ETHYL)PHENYL ETHER AMMONIUM SULFATES4S9783N13IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)GMR4PEN8PKIACT
WATER059QF0KO0RIACT

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
c2b5a5e5-9442-4e6b-e053-2a95a90a886d07b99bf0-18d2-407f-8867-d6d518f3d3302021-05-19WarningsExact identifier
spl set id: 07b99bf0-18d2-407f-8867-d6d518f3d330

Reported adverse events (FAERS/openFDA)#

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