PURELL ANTIMICROBIAL FOAM- chlorhexidine gluconate 2% solution liquid

Purell Antimicrobial Foam by

Drug Labeling and Warnings

Purell Antimicrobial Foam by is a Otc medication manufactured, distributed, or labeled by GOJO Industries, Inc., Xttrium Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

chlorhexidine gluconate 2% solution

Purpose

Antiseptic

Uses

healthare personnel handwash: helps reduce bacteria that can potentially cause disease

surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Warnings

For external use only

Allergy alert:

This product may cause severe allergic reaction. Symptoms may include:

wheezing/difficulty breathing

shock

facial swelling

hives

rash

If an allergic reaction occurs, stop use and seek medical help right away.

Do not use

if you are allergic to chlorhexidine gluconate or any other ingredient in this product

When using this product

keep out of eyes, ears and mouth. May cause serious and permenant eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums.

if solution should contact these areas, rinse out promptly and thoroughly with water

do not use routinely if you have wounds which involve more than the superficial layers of the skin

Stop use and ask a doctor if

irritation, sensitization. or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children

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

Directions

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Healthcare personnel handwash:

wet hands with water

dispense 5mL of product (6 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds

rinse and dry throughly

Surgical hand scrub:

wet hands and forearms with water

scrub for 3 minutes with 5mL of product (6 full strokes), with a wet brush, paying close attention to the nails, cuticles and skin between the fingers

a seperate nail cleaner may be used

rinse thoroughly

wash for an additional 3 minutes with 5mL of product (6 full strokes) and rinse under running water and dry throughly

Other information

store at 20-25°C (68-77°F)

avoid excessive heat above 40°C (104°F)

Inactive ingredients

citric acid, comide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide. purified water

PRINCIPAL DISPLAY PANEL

Purell

Healthcare

FOAM HANDWASH

2% CHG

Antimicrobial Foam

GOJOCSFLBLA

7887-641-F

NDC: 21749-225-58

Purell

Healthcare FOAM HANDWASH 2% CHG

Antimicrobial Foam

Distributed by: GOJO Industries, Inc. Akron, OH 44309

800-321-9647 330-255-6000 www.GOJO.com ©2019, GOJO Industries, Inc.

All rights reserved. Made in U.S.A.

GOJOCS4BLBLA

5181-642-ES-B

42 fl oz (1250 mL)

NDC: 21749-225-57

Purell

Healthcare FOAM HANDWASH 2% CHG

Antimicrobial Foam

Distributed by: GOJO Industries, Inc. Akron, OH 44309

800-321-9647 330-255-6000 www. GOJO.com ©2019. GOJO Industries, Inc.

All rights reserved. Made in U.S.A.

GOJOCS6BLBLA

6581-642-ES-B

40.5 FL OZ (1200 mL)

NDC: 21749-225-56

Purell

Healthcare FOAM HANDWASH 2% CHG

Antimicrobial Foam

Distributed by: GOJO Industries, Inc. Akron, OH 44309

800-321-9647 330-255-6000 www.GOJO.com ©2019. GOJO Industries, Inc.

All rights reserved. Made in the USA with U.S. and foreign components

GOJOCS8BLBLA

7881-641-ES-B

40.5 FL OZ (1200 mL)

PRINCIPAL DISPLAY PANEL

HEALTHCARE

PURELL

FOAM

HANDWASH

CHLORHEXIDINE GLUCONATE

2% SOLUTION - ANTISEPTIC

40.5 fl oz (1200 mL)

GOJOESFLBL

7781-640-F

NDC: 21749-225-64

Purell

Healthcare

FOAM HANDWASH

2% CHG Antimicrobial Foam

40.5 fl oz (1200 mL)

GOJOES4BLBL

5081-640-B

NDC: 21749-225-68

Purell

Healthcare

FOAM HANDWASH

2% CHG Antimicrobial Foam

40.5 fl oz (1200 mL)

GOJOES8BLBL

7781-640-B

INGREDIENTS AND APPEARANCE

PURELL ANTIMICROBIAL FOAM 
chlorhexidine gluconate 2% solution liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21749-225
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21749-225-58	1250 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018
2	NDC: 21749-225-57	1200 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018
3	NDC: 21749-225-56	1200 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018
4	NDC: 21749-225-64	1200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/01/2019
5	NDC: 21749-225-68	1200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019422	02/01/2018

Labeler - GOJO Industries, Inc. (004162038)

Registrant - Xttrium Laboratories, Inc. (007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc.		007470579	manufacture(21749-225)