Bactoshield®

Bactoshield®
SPL v3
SPL
SPL Set ID da5d244d-e9c1-45a5-8f4e-ed1d3b9d02a9
Route
TOPICAL
Published
Effective Date 2025-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (20 mg)
Inactive Ingredients
Water Coco Diethanolamide Cocamine Oxide Gluconic Acid Gluconolactone Hydroxyethyl Cellulose (5000 Mpa.s At 1%) Isopropyl Alcohol Peg-75 Lanolin Peg-150 Distearate Propylene Glycol Quaternium-33

Identifiers & Packaging

Marketing Status
NDA Active Since 2019-11-15 Until 2023-12-31

Description

Drug Facts

Purpose

Surgical hand scrub Healthcare personnel handwash Skin wound and general skin cleanser


Medication Information

Purpose

Surgical hand scrub Healthcare personnel handwash Skin wound and general skin cleanser

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: handwash to help reduce bacteria that potentially can cause disease
  • skin wound and general skin cleanser: helps reduce bacteria on the skin
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 and lasts for 72 hours. These may be signs of a serious condition.

Purposes

Surgical hand scrub

Healthcare personnel handwash

Skin wound and general skin cleanser

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.
  • use full strength
  • do not dilute
Do Not Use
  • if you are allergic to chlorhexidine gluconate or any other ingredient in this preparation
  • as a patient preoperative skin preparation (especially on the head or face)
  • in contact with meninges
  • in the genital area
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 solution, 2%

Other Information
  • store between 20-25°C (68-77°F)
  • avoid excessive heat (above 104°F/40°C)
  • for additional information, see Safety Data Sheet (SDS)
  • if swallowed get medical help or contact a Poison Control Center immediately
Surgical Hand Scrub
  • remove jewelry
  • wet hands and forearms with water and apply 5 mL of the product
  • wash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces
  • rinse thoroughly with water
  • wash for an additional 3 minutes with 5 mL of the product and rinse under running water
  • dry thoroughly
Inactive Ingredients

cocamide DEA, cocamine oxide, fragrance, gluconic acid

contains one or more of these ingredients
, gluconolactone
, hydroxyethyl cellulose, isopropyl alcohol 4%, PEG-75 lanolin, PEG-150 distearate, propylene glycol, quaternium-60, water

Questions Or Comments?

Call 1-866-783-0422 Monday through Friday 8:00 AM to 5:00 PM CT.

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 contact occurs, rinse with cold water right away
  • 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 an underlying condition makes it necessary to reduce the bacterial population of the skin
Healthcare Personnel Handwash
  • wet hands with water
  • dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 30 seconds
  • rinse and dry thoroughly
Skin Wound and General Skin Cleanser
  • thoroughly rinse the area to be cleansed with water
  • apply the minimum amount of product necessary to cover the skin or wound area and wash gently. Rinse thoroughly with water.
  • rinse again thoroughly
Principal Display Panel 118 Ml Bottle Label

SCJ PROFESSIONAL™

HEALTHCARE

Bactoshield®

CHG 2%

Surgical Scrub

Chlorhexidine Gluconate 2% Solution Antiseptic

Surgical Scrub

2% CHG

Antimicrobial

REORDER #

1322-39

SAP # 4000000061

1322-52l(321)

Net Contents:

118mL (4 fl oz)

deb

SKIN CARE


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: handwash to help reduce bacteria that potentially can cause disease
  • skin wound and general skin cleanser: helps reduce bacteria on the skin
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 and lasts for 72 hours. These may be signs of a serious condition.

Purposes

Surgical hand scrub

Healthcare personnel handwash

Skin wound and general skin cleanser

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.
  • use full strength
  • do not dilute
Do Not Use (Do not use)
  • if you are allergic to chlorhexidine gluconate or any other ingredient in this preparation
  • as a patient preoperative skin preparation (especially on the head or face)
  • in contact with meninges
  • in the genital area
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 solution, 2%

Other Information (Other information)
  • store between 20-25°C (68-77°F)
  • avoid excessive heat (above 104°F/40°C)
  • for additional information, see Safety Data Sheet (SDS)
  • if swallowed get medical help or contact a Poison Control Center immediately
Surgical Hand Scrub (Surgical hand scrub)
  • remove jewelry
  • wet hands and forearms with water and apply 5 mL of the product
  • wash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces
  • rinse thoroughly with water
  • wash for an additional 3 minutes with 5 mL of the product and rinse under running water
  • dry thoroughly
Inactive Ingredients (Inactive ingredients)

cocamide DEA, cocamine oxide, fragrance, gluconic acid

contains one or more of these ingredients
, gluconolactone
, hydroxyethyl cellulose, isopropyl alcohol 4%, PEG-75 lanolin, PEG-150 distearate, propylene glycol, quaternium-60, water

Questions Or Comments? (Questions or comments?)

Call 1-866-783-0422 Monday through Friday 8:00 AM to 5:00 PM CT.

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 contact occurs, rinse with cold water right away
  • 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 an underlying condition makes it necessary to reduce the bacterial population of the skin
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 30 seconds
  • rinse and dry thoroughly
Skin Wound and General Skin Cleanser (Skin wound and general skin cleanser)
  • thoroughly rinse the area to be cleansed with water
  • apply the minimum amount of product necessary to cover the skin or wound area and wash gently. Rinse thoroughly with water.
  • rinse again thoroughly
Principal Display Panel 118 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label)

SCJ PROFESSIONAL™

HEALTHCARE

Bactoshield®

CHG 2%

Surgical Scrub

Chlorhexidine Gluconate 2% Solution Antiseptic

Surgical Scrub

2% CHG

Antimicrobial

REORDER #

1322-39

SAP # 4000000061

1322-52l(321)

Net Contents:

118mL (4 fl oz)

deb

SKIN CARE


Advanced Ingredient Data


Raw Label Data

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