Xtt Cvs 4% Chg 8oz, 8oz Ca, 16oz, 16oz Ca,

Xtt Cvs 4% Chg 8oz, 8oz Ca, 16oz, 16oz Ca,
SPL v11
SPL
SPL Set ID 48a814e7-bfe4-5437-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2023-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (4 g)
Inactive Ingredients
Gluconolactone Peg-75 Lanolin Tridecyl Alcohol Coco Diethanolamide Hydroxyethyl Cellulose (2000 Cps At 1%) Isopropyl Alcohol Lauramine Oxide Water

Identifiers & Packaging

Marketing Status
NDA Active Since 2011-08-31 Until 2027-01-31
Description

Chlorhexidine gluconate 4% Solution

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Chlorhexidine gluconate 4% Solution

Uses

  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • skin wound and general cleansing
Section 43683-2

Uses

Doseage and Adminisration

Section 55106-9

Chlorhexidine gluconate 4% Solution

Warnings

For external use only

Allergy alert:

This product may cause a 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.

Direction
  • 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 about 5 ml of product into cupped hands and wash in a vigorous manner for about 15 seconds
  • rinse and dry thoroughly

Skin wound and general skin cleansing:

  • thoroughly rinse the area to be cleaned with water
  • apply the minimum amount of product necessary to cover the skin or wound area and wash gently
  • rinse again thoroughly
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

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

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

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

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

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

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
Other Information
  • store at 20-25 C (68-77 F)
  • avoid excessive heat above 40 C (104 F)

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

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.

Structured Label Content

Uses

  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • skin wound and general cleansing
Section 43683-2 (43683-2)

Uses

Doseage and Adminisration

Section 55106-9 (55106-9)

Chlorhexidine gluconate 4% Solution

Purpose

Antiseptic

Warnings

For external use only

Allergy alert:

This product may cause a 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.

Direction
  • 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 about 5 ml of product into cupped hands and wash in a vigorous manner for about 15 seconds
  • rinse and dry thoroughly

Skin wound and general skin cleansing:

  • thoroughly rinse the area to be cleaned with water
  • apply the minimum amount of product necessary to cover the skin or wound area and wash gently
  • rinse again thoroughly
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

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

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

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

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

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

Do Not Use (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
Other Information (other information)
  • store at 20-25 C (68-77 F)
  • avoid excessive heat above 40 C (104 F)

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-587-3721

When Using This Product (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 (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 (Keep out of reach of children)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:31.560100 · Updated: 2026-03-14T23:11:05.615438