ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate 4% liquid 
Chain Drug Marketing Association Inc.

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Quality Choice Drug Facts

Active Ingredients

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

  • 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

Keep out of reach of children.

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

Stop use and ask doctor if

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

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 procider

Directions

Healthcare personnel handwash:

Skin wound and normal 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 of comments?

1-800-587-3721

Other Information

DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

Warning: This product contains a chemical (cocamide DEA) known to the State of California to cause cancer.

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

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

Warning: Cancer - www.P65Warnings.gov

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach.

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

Package label and principal display panel

Quality Choice

NDC 63868-940-08

Compare to the active ingredient in HIBICLENS®*

Antiseptic Skin Cleanser

Antiseptic/Antimicrobial Skin Cleanser

Chlorhexidine Gluconate 4% Solution

Reduces Bacteria on the Skin

Net Contents: 8FL OZ (237 mL) BOTTLE

FOR EXTERNAL USE ONLY

DYE FREE

1061QC08LBLG

Quality Choice Single Panel

ANTISEPTIC SKIN CLEANSER 
chlorhexidine gluconate 4% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-940
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
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
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:63868-940-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912505/01/2014
Labeler - Chain Drug Marketing Association Inc. (011920774)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.007470579manufacture(63868-940)

Revised: 11/2023
Document Id: 0b390371-8d11-ac69-e063-6294a90ab76b
Set id: 12234b17-fd07-6088-e054-00144ff88e88
Version: 6
Effective Time: 20231128
 
Chain Drug Marketing Association Inc.