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

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XTT CVS 4% CHG 8oz, 8oz CA, 16oz, 16oz CA, 18oz, 18oz CA

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

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
  • wound 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 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.

Direction

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?

1-800-587-3721

Packaging

CVS Health

Compare to the active ingredient in Hibiclens®

NDC 59779-767-08

Antiseptic Skin Cleanser

CHLORHEXIDINE GLUCONATE 4% SOLUTION

Antiseptic / Antimicrobial skin cleanser

For external use only

TAMPER EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING

8 fl oz (237 mL)

4CVS08BTLLBLG

8oz CVS single panel

CVS Health

Comapre to the active ingredient in Hibiclens®

NDC 59779-767-08

Antiseptic Skin Cleanser

CHLORHEXIDINE GLUCONATE 4% SOLUTION

Antiseptic / Antimicrobial skin cleanser

For external use only

TAMPER EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING

8 fl oz (237 mL)

4CVS08LBL4CAD

8oz CA CVS single panel

CVS Health

Compare to the active ingredient in Hibiclens®

NDC 59779-767-16

Antiseptic Skin Cleanser

CHLORHEXIDINE GLUCONATE 4% SOLUTION

Antiseptic / Antimicrobial skin cleanser

For external use only

TAMPER EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING

16 fl oz (473 mL)

4CVS16BTLLBLB

16oz CVS single panel

CVS Health

Comapre to the active ingredient in Hibiclens®

NDC 59779-767-16

Antiseptic Skin Cleanser

CHLORHEXIDINE GLUCONATE 4% SOLUTION

Antiseptic / Antimicrobial skin cleanser

For external use only

TAMPER EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING

16 fl oz (473 mL)

4CVS16LBL4CAC

16oz CVS CA single panel

CVS Health

Comapre to the active ingredient in Hibiclens®

NDC 59779-767-18

FOAMING

Antiseptic Skin Cleanser

CHLORHEXIDINE GLUCONATE 4% SOLUTION

Antiseptic / Antimicrobial skin cleanser

Clinically proven to reduce bacteria on skin

18 fl oz (532 mL)

For external use only

4CVS18FMBTLLBLA

18oz CVS single panel

CVS Health

Compare to the active ingredient in Hibiclens®

NDC 59779-767-18

FOAMING

Antiseptic Skin Cleanser

CHLORHEXIDINE GLUCONATE 4% SOLUTION

Antiseptic / Antimicrobial skin cleanser

Clinically proven to reduce bacteria on skin

18 fl oz (532 mL)

For external use only

4CVS18FMLBLCAA

18oz CVS CA single panel

ANTISEPTIC SKIN CLEANSER 
chlorhexidine gluconate 4% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-0767
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
TRIDECYL ALCOHOL (UNII: 8I9428H868)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0116-0767-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2011
2NDC:0116-0767-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2017
3NDC:0116-0767-18532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/14/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912508/31/2011
Labeler - Xttrium Laboratories, Inc. (007470579)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.007470579manufacture(0116-0767)

Revised: 12/2023
Document Id: 0c7ed4df-8e3e-7b4f-e063-6294a90a494c
Set id: 48a814e7-bfe4-5437-e054-00144ff88e88
Version: 9
Effective Time: 20231214
 
Xttrium Laboratories, Inc.