Xtt 4% Hr Pharma 16oz, & 32oz

Xtt 4% Hr Pharma 16oz, & 32oz
SPL v5
SPL
SPL Set ID f8352f15-b481-ee95-e053-6294a90ac535
Route
TOPICAL
Published
Effective Date 2023-12-19
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 Water Lauramine Oxide

Identifiers & Packaging

Marketing Status
NDA Completed Since 2023-03-23 Until 2025-10-31

Description

Chlorhexidine gluconate 4% Solution

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Chlorhexidine gluconate 4% Solution

Uses
  • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • skin wound and general cleansing
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.

Surgical hand scrub:

  • wet hands and forearms with water
  • scrub for 3 minutes with about 5 mL of product and a wet brush paying close attention to the nails, cuticles, and interdigital spaces
  • a separate nail cleaner may be used
  • rinse throughly
  • wash for an additional 3 minutes with 5 mL of product and rinse under running water
  • dry thoroughly

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

NDC 69464-901-08

REF 90208

CliniClean

Chlorhexidine Gluconate 4%

Antiseptic/Antimicrobial Solution

Surgical Hand Scrub, Healthcare Personnel Hand Wash, General Skin & Wound Cleanser

Net Contents: 8 fl oz (237 mL)

DYE FREE

Manufactured for:

HR Pharmaceutials, Inc.

York, PA 17402

cliniclean.com

4171 Rev 1

(10/2023)

4HRP08BTLLBLA

NDC 69464-901-16

REF 90316

CliniClean

Chlorhexidine Gluconate 4%

Antiseptic/Antimicrobial Solution

Surgical Hand Scrub, Healthcare Personnel Hand Wash, General Skin & Wound Cleanser

Net Contents: 16 fl oz (473 mL)

DYE FREE

Manufactured for:

HR Pharmaceutials, Inc.

York, PA 17402

cliniclean.com

4172 Rev 1

(10/2023)

4HRP16BTLLBLA

NDC 69464-901-32

REF 90432

CliniClean

Chlorhexidine Gluconate 4%

Antiseptic/Antimicrobial Solution

Surgical Hand Scrub, Healthcare Personnel Hand Wash, General Skin & Wound Cleanser

Net Contents: 32 fl oz (946 mL)

DYE FREE

Manufactured for:

HR Pharmaceutials, Inc.

York, PA 17402

cliniclean.com

Rev 4171-0 (02/2023)

4HRP32BTLLBL

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 ºC (68-77 ºF)
  • avoid excessive heat above 40 ºC (104 ºF)
Inactive Ingredients

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

Questions Or Comments?

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

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.

Laundry/cleaning Instrucations

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.


Structured Label Content

Uses
  • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • skin wound and general cleansing
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.

Surgical hand scrub:

  • wet hands and forearms with water
  • scrub for 3 minutes with about 5 mL of product and a wet brush paying close attention to the nails, cuticles, and interdigital spaces
  • a separate nail cleaner may be used
  • rinse throughly
  • wash for an additional 3 minutes with 5 mL of product and rinse under running water
  • dry thoroughly

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

NDC 69464-901-08

REF 90208

CliniClean

Chlorhexidine Gluconate 4%

Antiseptic/Antimicrobial Solution

Surgical Hand Scrub, Healthcare Personnel Hand Wash, General Skin & Wound Cleanser

Net Contents: 8 fl oz (237 mL)

DYE FREE

Manufactured for:

HR Pharmaceutials, Inc.

York, PA 17402

cliniclean.com

4171 Rev 1

(10/2023)

4HRP08BTLLBLA

NDC 69464-901-16

REF 90316

CliniClean

Chlorhexidine Gluconate 4%

Antiseptic/Antimicrobial Solution

Surgical Hand Scrub, Healthcare Personnel Hand Wash, General Skin & Wound Cleanser

Net Contents: 16 fl oz (473 mL)

DYE FREE

Manufactured for:

HR Pharmaceutials, Inc.

York, PA 17402

cliniclean.com

4172 Rev 1

(10/2023)

4HRP16BTLLBLA

NDC 69464-901-32

REF 90432

CliniClean

Chlorhexidine Gluconate 4%

Antiseptic/Antimicrobial Solution

Surgical Hand Scrub, Healthcare Personnel Hand Wash, General Skin & Wound Cleanser

Net Contents: 32 fl oz (946 mL)

DYE FREE

Manufactured for:

HR Pharmaceutials, Inc.

York, PA 17402

cliniclean.com

Rev 4171-0 (02/2023)

4HRP32BTLLBL

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 ºC (68-77 ºF)
  • avoid excessive heat above 40 ºC (104 ºF)
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?)

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

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.

Laundry/cleaning Instrucations (Laundry/Cleaning Instrucations)

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.


Advanced Ingredient Data


Raw Label Data

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