ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate 4% solution 
Henry Schein, Inc.

----------

Maxiclens

Active ingredient

Chlorhexidine gluconate 4% solution

Purpose

Antiseptic

Uses

Warnings

For external use only

Allergy alert: This product may cause a severe allergic reaction. Symptoms may include:

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

Do not use

When using this product

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

Surgical hand scrub:

Healthcare personnel handwash:

Skin wound and general skin cleansing:

Other information

Inactive ingredients

cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

Questions or comments?

call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents.

WARNING: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

Rev 7/2018

Active ingredient

Chlorhexidine gluconate 4% solution

Purpose

Antiseptic

Uses

Warnings

For external use only

Allergy alert: This product may cause a severe allergic reaction. Symptoms may include:

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

Do not use

When using this product

Stop use and ask a doctor if

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

Keeo out of reach of children.

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

Directions

Surgical hand scrub:

Healthcare personnel handwash:

Skin wound and general skin cleansing:

Other information

Inactive ingredients

cocamide DE, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

Questions or comments?

call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST

Laundering/Cleaning Instructions:

Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents.

WARNING: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

Rev 11/2018

431-0032

Henry Schein®

Maxiclens

Antiseptic Skin Cleasner

(Chlorhexidine Gluconate 4%)

FOR EXTERNAL USE ONLY

Net Contents

32 fl oz (1qt)(946-mL)

Made in U.S.A

Distributed By

HENRY SCHEIN INC.

135 Duryea Road

Melville, NY 11747 USA

4MAX32BTLLBL

Content of Labeling

Content of Labeling

Drug Facts 1

Drug Facts 2

Package label and principal display panel

NDC 0404-1061-01

431-0099

HENRY SCHEIN ®

Maxiclens

Antiseptic Skin Cleanser

(Chlorhexidine Gluconate 4%)

FOR EXTERNAL USE ONLY

Net Contents

128 fl oz (1 gal) (3.785 L)

Made in U.S.A.

Distributed By

HENRY SCHEIN INC.

135 Duryea Road

Melville, NY 11747 USA

4MAX1GBTLLBL

1-gallon PDP

1-gallon drug facts

1-gallon drug facts 2

ANTISEPTIC SKIN CLEANSER 
chlorhexidine gluconate 4% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-1061
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
WATER (UNII: 059QF0KO0R)  
TRIDECYL ALCOHOL (UNII: 8I9428H868)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-1061-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product04/02/2003
2NDC:0404-1061-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product04/02/2003
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912504/02/2003
Labeler - Henry Schein, Inc. (012430880)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories007470579manufacture(0404-1061)

Revised: 11/2018
Document Id: 7abc4c4c-8ab1-fa25-e053-2991aa0a766b
Set id: 78861ded-4134-f6e9-e053-2991aa0a6cb4
Version: 2
Effective Time: 20181115
 
Henry Schein, Inc.