Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 12af447c-5601-34d2-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2019-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
NDA Active Since 2012-10-30

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 skin cleaning

Section 60561-8

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

This product can expose you to a 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.

Warnings

For external use only

Allergy alert: This product may cause 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.

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

Skin wound and normal 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
Active Ingredient

Chlorhexidine gluconate 4% solution

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

Chlorhexidine Gluconate 4% Solution

Inactive Ingredients

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

Questions of Comments?

call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST.

Questions Or Comments?

call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST

Princical Display Panel

Premier Value

COMPARE TO THE ACTIVE INGREDIENT IN HIBICLENS ®*

Antiseptic Skin Cleanser

ANTISEPTIC/ANTIMICROBIAL SKIN CLEANSER

(Chlorhexidine Gluconate 4% Solution)

FOR EXTERNAL USE ONLY

DYE FREE

DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

16 fl oz (473 mL)

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
Other Safetly Information

4PV16BTLLBL

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.

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

MADE IN USA

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Stop Use and Ask Doctor If

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

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

Keep Out of Reach of Children.

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

Package Label and Principal Display Panel

Premier Value

COMPARE TO THE ACTIVE INGREDIENT IN HIBICLENS®

Antiseptic Skin Cleanser

Antiseptic/Antimicrobial Skin Cleanser

(Chlorhexidine Gluconate 4% solution)

FOR EXTERNAL USE ONLY

DYE FREE

DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

8FL OZ. (237 mL)


Structured Label Content

Uses

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

skin wound and general skin cleaning

Section 60561-8 (60561-8)

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

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

Purpose

Antiseptic

Warning

This product can expose you to a 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.

Warnings

For external use only

Allergy alert: This product may cause 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.

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

Skin wound and normal 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
Active Ingredient (Active ingredient)

Chlorhexidine gluconate 4% solution

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

Chlorhexidine Gluconate 4% Solution

Inactive Ingredients (Inactive ingredients)

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

Questions of Comments? (Questions of comments?)

call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST.

Questions Or Comments? (Questions or comments?)

call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST

Princical Display Panel

Premier Value

COMPARE TO THE ACTIVE INGREDIENT IN HIBICLENS ®*

Antiseptic Skin Cleanser

ANTISEPTIC/ANTIMICROBIAL SKIN CLEANSER

(Chlorhexidine Gluconate 4% Solution)

FOR EXTERNAL USE ONLY

DYE FREE

DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

16 fl oz (473 mL)

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
  • 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
Other Safetly Information

4PV16BTLLBL

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.

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

MADE IN USA

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Stop Use and Ask Doctor If (Stop use and ask doctor if)

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

Stop Use and Ask A Doctor If (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

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.

Package Label and Principal Display Panel (Package label and principal display panel)

Premier Value

COMPARE TO THE ACTIVE INGREDIENT IN HIBICLENS®

Antiseptic Skin Cleanser

Antiseptic/Antimicrobial Skin Cleanser

(Chlorhexidine Gluconate 4% solution)

FOR EXTERNAL USE ONLY

DYE FREE

DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

8FL OZ. (237 mL)


Advanced Ingredient Data


Raw Label Data

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