ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate 4% liquid 
Xttrium Laboratories, Inc.

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Sunmark McKesson 4%CHG

Active Ingredients

Chlorhexidine Gluconate 4% Solution

Purpose

Antiseptic

Uses

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

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

skin wound and general skin cleansing

Warnings

For external use only

Allergy alert:

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

wheezing/difficulty breathing

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

Do not use

  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with meninges
  • in the genital area

When using this product

  • keep out of eyes, ears, and mouth. May cause serious and permanent 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
  • wounds which involve more than the superficial layers of the skin should not be routinely treated
  • repeated general skin cleansing of large body areas should not be done except when advised by a health care provider

Stop use and ask 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.

Surgical hand scrub:

Healthcare personnel handwash:

Skin wound and general skin cleansing:

Other information

Inactive ingredients

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

Questions of comments?

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

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.gov

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

*This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.

sunmark

Compare to the active ingredient in Hibiclens­®

NDC 0116-0115-37

antiseptic skin cleanser

Chlorhexidine Gluconate 4% Solution

Antiseptic/Antimicrobial

Skin Cleanser

Dye Free

FOR EXTERNAL USE ONLY

NET CONTENTS: 8 fl oz (237 mL)

SM08 PDP

SM08 DF1

SM08 DF2

SM08 DF3

ANTISEPTIC SKIN CLEANSER 
chlorhexidine gluconate 4% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-0115
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE4 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
TRIDECYL ALCOHOL (UNII: 8I9428H868)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0116-0115-37237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/20/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912502/20/2014
Labeler - Xttrium Laboratories, Inc. (007470579)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.007470579manufacture(0116-0115)

Revised: 3/2020
Document Id: a18a2708-24d5-1183-e053-2a95a90a24dc
Set id: 4a65dfa5-5477-0983-e054-00144ff88e88
Version: 7
Effective Time: 20200323
 
Xttrium Laboratories, Inc.