PRO-SOURCE DISTRIBUTORS- pdi instant alcohol sanitizer liquid

Pro-Source by

Drug Labeling and Warnings

Pro-Source by is a Otc medication manufactured, distributed, or labeled by Inopak, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 70%

Purpose

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

When using

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

Stop Use

• Discontinue use if irritation occurs.

Keep away from children

Keep out of reach of children.

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 ingredient

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

Pro-Source PDI Individual label

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 Case label

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

INGREDIENTS AND APPEARANCE

PRO-SOURCE  DISTRIBUTORS
pdi instant alcohol sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	alcohol	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PEG-14 1-((METHYLPHENYL)ETHYL)PHENYL ETHER AMMONIUM SULFATE (UNII: S4S9783N13)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-201-01	1000 mL in 1 BAG; Type 0: Not a Combination Product	01/01/2018
2	NDC: 58575-201-02	6000 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2018

Labeler - Inopak, Ltd (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd		194718243	manufacture(58575-201)