Xtt 4% Hr Pharma 15 Ml Packets, 15ml Carton

Xtt 4% Hr Pharma 15 Ml Packets, 15ml Carton
SPL v3
SPL
SPL Set ID f8354044-6b99-6d2c-e053-6294a90a74b2
Route
TOPICAL
Published
Effective Date 2023-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
NDA Active 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
  • patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery
  • skin wound and general skin cleansing

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.

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

Healthcare personnel handwash:

  • wet hands with water
  • dispense about 5mL of product into cupped hands and wash in a vigrous manner for 15 seconds
  • rinse and dry thoroughly

Patient preoperative skin preparation:

  • apply product liberally to surgical site and swab for at least 2 minutes
  • dry with a sterile towel
  • repeat procedure for an additional 2 minutes and dry with a sterile towel

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 the meninges
  • in the genital area
Display Panels

NDC 69494-901-04

REF 90104

CliniClean

Chlorhexidine Gluconate 4%

Antispetic/Antimicrobial Solution

Non-Sterile

Patient Pre-Operative Prep, Surgical Hand Scrub, Healthcare Personnel Hand Wash. General Skin & Wound Cleanser

For Single-Use

Net Content: 4 fl oz (118mL)

DYE FREE

Manufactured for:

HR Pharmaceuticals, Inc.

York, PA 17402

cliniclean.com

Rev 4170-0 (02/2023)

4HRP04BTLLBL

NDC 69494-901-15

REF 901515

CliniClean

Chlorhexidine Gluconate 4%

Antispetic/Antimicrobial Solution

Non-Sterile

Patient Pre-Operative Prep, Surgical Hand Scrub, Healthcare Personnel Hand Wash. General Skin & Wound Cleanser

For Single-Use

Net Contents: 50 Single-Use 0.5 fl oz (15 mL) Packettes

DYE FREE

Manufactured for:

HR Pharmaceuticals, Inc.

York, PA 17402

cliniclean.com

Rev 4175-0 (02/2023)

4HRP15INNCTN

4HRP15PACKET

Active Ingredient

Chlorhexidine gluconate 4% solution

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?

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 placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardurms.
  • 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 healthcare 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.

Laudering/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.


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
  • patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery
  • skin wound and general skin cleansing

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.

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

Healthcare personnel handwash:

  • wet hands with water
  • dispense about 5mL of product into cupped hands and wash in a vigrous manner for 15 seconds
  • rinse and dry thoroughly

Patient preoperative skin preparation:

  • apply product liberally to surgical site and swab for at least 2 minutes
  • dry with a sterile towel
  • repeat procedure for an additional 2 minutes and dry with a sterile towel

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 the meninges
  • in the genital area
Display Panels

NDC 69494-901-04

REF 90104

CliniClean

Chlorhexidine Gluconate 4%

Antispetic/Antimicrobial Solution

Non-Sterile

Patient Pre-Operative Prep, Surgical Hand Scrub, Healthcare Personnel Hand Wash. General Skin & Wound Cleanser

For Single-Use

Net Content: 4 fl oz (118mL)

DYE FREE

Manufactured for:

HR Pharmaceuticals, Inc.

York, PA 17402

cliniclean.com

Rev 4170-0 (02/2023)

4HRP04BTLLBL

NDC 69494-901-15

REF 901515

CliniClean

Chlorhexidine Gluconate 4%

Antispetic/Antimicrobial Solution

Non-Sterile

Patient Pre-Operative Prep, Surgical Hand Scrub, Healthcare Personnel Hand Wash. General Skin & Wound Cleanser

For Single-Use

Net Contents: 50 Single-Use 0.5 fl oz (15 mL) Packettes

DYE FREE

Manufactured for:

HR Pharmaceuticals, Inc.

York, PA 17402

cliniclean.com

Rev 4175-0 (02/2023)

4HRP15INNCTN

4HRP15PACKET

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)

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 placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardurms.
  • 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 healthcare provider
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.

Laudering/cleaning Instructions (Laudering/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.


Advanced Ingredient Data


Raw Label Data

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