Cvs 4% 8oz, 8oz Ca, 16oz, 16oz Ca, 18oz, 18oz Ca

Cvs 4% 8oz, 8oz Ca, 16oz, 16oz Ca, 18oz, 18oz Ca
SPL v8
SPL
SPL Set ID 46dc074c-af71-4805-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2023-11-06
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: removal of surgical handscub indication (11/23)

Directions : removal of surgical handscrub indication (11/23)

Section 55106-9

Chlorhexidine gluconate 4% Solution

Section 60561-8

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

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 only non-chlorine detergents.

Warnings

For external use only

Allergy alert:

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

  • wheezing
  • shock
  • facial swelling
  • hives
  • rash

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

Packaging

CVS Health Compare to the active ingredient in Hibiclens®*

NDC 59779-767-08

Chlorhexidine Gluconate 4% Solution

Antiseptic Skin Cleanser

Antiseptic Antimicrobial skin cleanser

For external use only

Dye Free

Distributed by:

CVS Pharmacy, Inc.

Woonsocket, RI 02985

©2023 CVS/pharmacy V-10220

4CVS08BTLLBLG

8FL OZ (237mL)

This product is not manufactured or distributed

by Mölnlycke Healthcare, owner of the registered

trademark Hibiclens®.

4CVS08LBL4CAD

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.

CVS Health Compare to the active ingredient in Hibiclens®*

NDC 59779-767-16

Chlorhexidine Gluconate 4% Solution

Antiseptic Skin Cleanser

Antiseptic Antimicrobial skin cleanser

For external use only

Dye Free

Distributed by:

CVS Pharmacy, Inc.

Woonsocket, RI 02985

© 2023 CVS/pharmacy V-10220

4CVS16BTLLBLA

16FL OZ (473mL)

This product is not manufactured or distributed

by Mölnlycke Healthcare, owner of the registered

trademark Hibiclens®.

4CVS16LBL4CAC

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.

CVS Health Compare to the active ingredient in Hibiclens®*

NDC 59779-767-18

Chlorhexidine Gluconate 4% Solution

Antiseptic Skin Cleanser

Antiseptic Antimicrobial skin cleanser

For external use only

Dye Free

Distributed by:

CVS Pharmacy, Inc.

Woonsocket, RI 02985

4CVS18FMBTLLBLA

18FL OZ (532mL)

© 2023 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

This product is not manufactured or distributed

by Mölnlycke Healthcare, owner of the registered

trademark Hibiclens®.

how2recycle.info

100% money back gurantee. CVS.com/returnpolicy

4CVS18FMLBLCAA

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.

Directions
  • 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 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
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
Questions?

1-800-587-3721

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

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 the 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: removal of surgical handscub indication (11/23)

Directions : removal of surgical handscrub indication (11/23)

Section 55106-9 (55106-9)

Chlorhexidine gluconate 4% Solution

Section 60561-8 (60561-8)

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

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 only non-chlorine detergents.

Purpose

Antiseptic

Warnings

For external use only

Allergy alert:

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

  • wheezing
  • shock
  • facial swelling
  • hives
  • rash

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

Packaging

CVS Health Compare to the active ingredient in Hibiclens®*

NDC 59779-767-08

Chlorhexidine Gluconate 4% Solution

Antiseptic Skin Cleanser

Antiseptic Antimicrobial skin cleanser

For external use only

Dye Free

Distributed by:

CVS Pharmacy, Inc.

Woonsocket, RI 02985

©2023 CVS/pharmacy V-10220

4CVS08BTLLBLG

8FL OZ (237mL)

This product is not manufactured or distributed

by Mölnlycke Healthcare, owner of the registered

trademark Hibiclens®.

4CVS08LBL4CAD

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.

CVS Health Compare to the active ingredient in Hibiclens®*

NDC 59779-767-16

Chlorhexidine Gluconate 4% Solution

Antiseptic Skin Cleanser

Antiseptic Antimicrobial skin cleanser

For external use only

Dye Free

Distributed by:

CVS Pharmacy, Inc.

Woonsocket, RI 02985

© 2023 CVS/pharmacy V-10220

4CVS16BTLLBLA

16FL OZ (473mL)

This product is not manufactured or distributed

by Mölnlycke Healthcare, owner of the registered

trademark Hibiclens®.

4CVS16LBL4CAC

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.

CVS Health Compare to the active ingredient in Hibiclens®*

NDC 59779-767-18

Chlorhexidine Gluconate 4% Solution

Antiseptic Skin Cleanser

Antiseptic Antimicrobial skin cleanser

For external use only

Dye Free

Distributed by:

CVS Pharmacy, Inc.

Woonsocket, RI 02985

4CVS18FMBTLLBLA

18FL OZ (532mL)

© 2023 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

This product is not manufactured or distributed

by Mölnlycke Healthcare, owner of the registered

trademark Hibiclens®.

how2recycle.info

100% money back gurantee. CVS.com/returnpolicy

4CVS18FMLBLCAA

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.

Directions
  • 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 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
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
Questions?

1-800-587-3721

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

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 the 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)