Bactoshield ®

Bactoshield ®
SPL v7
SPL
SPL Set ID 4a5483c2-10b7-0f08-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2014-06-05
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 Active Since 1999-10-04

Description

Drug Facts

Purpose

surgical hand scrub healthcare personnel handwash patient preoperative skin preparation skin wound and general skin cleansing


Medication Information

Purpose

surgical hand scrub healthcare personnel handwash patient preoperative skin preparation skin wound and general skin cleansing

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 43683-2

Dosage and Administration

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.

Section 51945-4

Bactoshield ® CHG 2%

NDC 11084-814-03

Surgical Scrub

Chlorhexidine Gluconate 2% Solution Antiseptic

Non-sterile Solution

Surgical Scrub

2% CHG

Antimicrobial

For Single-Use

Net Contents: 118 mL (4 fl oz)

1322-52G(319)

REORDER #1322-39

61345

2BACT04BTLLBLE

Bactoshield® CHG 2%

NDC 11084-814-24

Surgical Scrub

2% Solution Antiseptic

Chlorhexidine Gluconate

Surgical Scrub

2% CHG

Antimicrobial

Net Contents: 32 fl oz (946 mL)

REORDER #1322-24

61335

1322-21J(319)

2BACT32BTLLBLJ

Bactoshield ® CHG 2%

NDC 11084-814-08

Surgical Scrub

Chlorhexidine Gluconate 2% Solution Antiseptic

Surgical Scrub

2% CHG

Antimicrobial

Net Contents: 128 fl oz (1Gal)(3.78 Liters)

1322-06G(319)

REORDER #1322-08

62662

2BACT1GLBLB

NDC 11084-814-41

Bactoshield CHG 2%

Chlorhexidine Gluconate 2% Solution

Antiseptic

Healthcare Personnel Handwash

REORDER #: 1322-87

Manufactured for:

Deb USA, Inc.

Charlotte, NC 28217

1-866-783-0422

www.debmed.com

Contents: 33.8 fl oz (1.05 qt) (1 Liter)

61707

1322-86K (319)

SDSNATBKLBLA

NDC 11084-814-41

SDSNATFTLBLA

Section 60561-8

WARNING: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause. For more information go to www.P65Warnings.ca.gov

Purposes

surgical hand scrub

healthcare personnel handwash

patient preoperative skin preparation

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 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 the 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

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
  • 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 e 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 2% solution

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

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

Questions Or Comments?

Call 1-800-548-4873 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

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 43683-2 (43683-2)

Dosage and Administration

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.

Section 51945-4 (51945-4)

Bactoshield ® CHG 2%

NDC 11084-814-03

Surgical Scrub

Chlorhexidine Gluconate 2% Solution Antiseptic

Non-sterile Solution

Surgical Scrub

2% CHG

Antimicrobial

For Single-Use

Net Contents: 118 mL (4 fl oz)

1322-52G(319)

REORDER #1322-39

61345

2BACT04BTLLBLE

Bactoshield® CHG 2%

NDC 11084-814-24

Surgical Scrub

2% Solution Antiseptic

Chlorhexidine Gluconate

Surgical Scrub

2% CHG

Antimicrobial

Net Contents: 32 fl oz (946 mL)

REORDER #1322-24

61335

1322-21J(319)

2BACT32BTLLBLJ

Bactoshield ® CHG 2%

NDC 11084-814-08

Surgical Scrub

Chlorhexidine Gluconate 2% Solution Antiseptic

Surgical Scrub

2% CHG

Antimicrobial

Net Contents: 128 fl oz (1Gal)(3.78 Liters)

1322-06G(319)

REORDER #1322-08

62662

2BACT1GLBLB

NDC 11084-814-41

Bactoshield CHG 2%

Chlorhexidine Gluconate 2% Solution

Antiseptic

Healthcare Personnel Handwash

REORDER #: 1322-87

Manufactured for:

Deb USA, Inc.

Charlotte, NC 28217

1-866-783-0422

www.debmed.com

Contents: 33.8 fl oz (1.05 qt) (1 Liter)

61707

1322-86K (319)

SDSNATBKLBLA

NDC 11084-814-41

SDSNATFTLBLA

Section 60561-8 (60561-8)

WARNING: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause. For more information go to www.P65Warnings.ca.gov

Purposes

surgical hand scrub

healthcare personnel handwash

patient preoperative skin preparation

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 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 the 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

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
  • 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 e 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 2% 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)

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

Questions Or Comments? (Questions or comments?)

Call 1-800-548-4873 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

Advanced Ingredient Data


Raw Label Data

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