Bactoshield Chg

Bactoshield Chg
SPL v2
SPL
SPL Set ID 46084e90-6ffa-4e1a-a8ff-1c1b1484fe88
Route
TOPICAL
Published
Effective Date 2022-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (20 mg)
Inactive Ingredients
Citric Acid Monohydrate Coco Diethanolamide Hydroxyethyl Cellulose (100 Mpa.s At 2%) Isopropyl Alcohol Lauramine Oxide Water

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
NDA Completed Since 2022-12-01 Until 2027-12-31

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

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Warnings

For external use only

Directions
  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
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
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.

Active Ingredient

Chlorhexidine gluconate 2% solution

Other Information
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
Surgical Hand Scrub
  • wet hands and forearms under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner.
  • scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers
  • rinse thoroughly under running water for 30 seconds
  • wash for an additional 1.5 minutes with 8 mL of product and rinse under running water for 30 seconds
  • dry thoroughly
Inactive Ingredients

citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

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
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 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
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
Principal Display Panel 118 Ml Bottle Label

Bactoshield®

CHG 2%

Surgical Scrub

Chlorhexidine Gluconate 2% Solution Antiseptic

Non-Sterile Solution

SCJ PROFESSIONAL

HEALTHCARE

NDC 11084-038-03

Surgical Scrub

2% CHG

Antimicrobial

REORDER #

1322-39

SAP # 4000011062

1322-52J(622)

2SCJ04BTLLBL

deb

SKIN CARE

Net Contents:

4 fl oz (118 mL)

For Single Use


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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Purpose

Antiseptic

Warnings

For external use only

Directions
  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
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
Allergy Alert (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.

Active Ingredient (Active ingredient)

Chlorhexidine gluconate 2% solution

Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
Surgical Hand Scrub (Surgical hand scrub)
  • wet hands and forearms under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner.
  • scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers
  • rinse thoroughly under running water for 30 seconds
  • wash for an additional 1.5 minutes with 8 mL of product and rinse under running water for 30 seconds
  • dry thoroughly
Inactive Ingredients (Inactive ingredients)

citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

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
Healthcare Personnel Handwash (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 Cleaning (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
Patient Preoperative Skin Preparation (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
Principal Display Panel 118 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label)

Bactoshield®

CHG 2%

Surgical Scrub

Chlorhexidine Gluconate 2% Solution Antiseptic

Non-Sterile Solution

SCJ PROFESSIONAL

HEALTHCARE

NDC 11084-038-03

Surgical Scrub

2% CHG

Antimicrobial

REORDER #

1322-39

SAP # 4000011062

1322-52J(622)

2SCJ04BTLLBL

deb

SKIN CARE

Net Contents:

4 fl oz (118 mL)

For Single Use


Advanced Ingredient Data


Raw Label Data

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