Scj 4oz 4% Chg Bactoshield

Scj 4oz 4% Chg Bactoshield
SPL v3
SPL
SPL Set ID ee0317ff-0988-7621-e053-2a95a90a13fe
Route
TOPICAL
Published
Effective Date 2023-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (2 mg)
Inactive Ingredients
Lauramine Oxide Hydroxyethyl Cellulose (2000 Cps At 1%) Isopropyl Alcohol Gluconolactone Water Coco Diethanolamide Peg-75 Lanolin Tridecyl Alcohol

Identifiers & Packaging

Marketing Status
NDA Active Since 2022-11-21

Description

Drug Facts

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Drug Facts

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: preparation of the patient's skin prior to surgery
  • skin wound and general skin cleansing
Section 42229-5

Drug Facts

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.

Packaging

SCJ Professional

Healthcare

Bactoshield

CHG 4%

NDC 11084-039-03

Surgical Scrub

Chlorhexidine Gluconate 4% Solution Antiseptic

Non-Sterile Solution

Surgical Scrub

4% CHG

Antimicrobial

REORDER#

1344-39

SAP # 4000011061

1344-52J(123)

4SCJ04BTLLBLA

deb

SKIN CARE

For Single Use

Net Contents:

4 fl oz (118 mL)

Manufactured for: SCJ Professional USA, Inc.

Charlotte, NC 28217

1-866-783-0422 www.scjp.com

WARNING: Cancer -- www.P65Warnings.ca.gov. Keep from freezing.

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 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 thoroughly
  • 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 15 seconds
  • rinse and dry thoroughly

Patient preoperative skin preparation:

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

Skin wound and general skin cleaning:

  • 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
  • as a preoperative skin preparation of the head or face
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 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
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.

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.


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: preparation of the patient's skin prior to surgery
  • skin wound and general skin cleansing
Section 42229-5 (42229-5)

Drug Facts

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.

Packaging

SCJ Professional

Healthcare

Bactoshield

CHG 4%

NDC 11084-039-03

Surgical Scrub

Chlorhexidine Gluconate 4% Solution Antiseptic

Non-Sterile Solution

Surgical Scrub

4% CHG

Antimicrobial

REORDER#

1344-39

SAP # 4000011061

1344-52J(123)

4SCJ04BTLLBLA

deb

SKIN CARE

For Single Use

Net Contents:

4 fl oz (118 mL)

Manufactured for: SCJ Professional USA, Inc.

Charlotte, NC 28217

1-866-783-0422 www.scjp.com

WARNING: Cancer -- www.P65Warnings.ca.gov. Keep from freezing.

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 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 thoroughly
  • 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 15 seconds
  • rinse and dry thoroughly

Patient preoperative skin preparation:

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

Skin wound and general skin cleaning:

  • 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
  • as a preoperative skin preparation of the head or face
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 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
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.

Laundering/cleaning Instructions: (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.


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Raw Label Data

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