Bactoshield Chg Solution
FDA Label NDC 11084-039

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sc Johnson Professional Usa, Inc. for the product Bactoshield Chg (NDC 11084-039). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, allergy alert, do not use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Active Ingredient

Chlorhexidine gluconate 4% solution

Purpose

Antiseptic

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
  • 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.

Do Not Use

  • if you or the patient are allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with meninges
  • in the genital area

When Using This Product

  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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

Otc - Stop Use

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

Otc - 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.

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

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

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

Principal Display Panel - 946 Ml Bottle Label

SCJ PROFESSIONAL
HEALTHCARE

Bactoshield®
CHG 4%

NDC 11084-039-24

Surgical Scrub
Chlorhexidine Gluconate 4%
Solution Antiseptic

Surgical Scrub

4% CHG

Antimicrobial

Net Contents: 32 fl oz (946 mL)

REORDER #
1344-24

1344-21K(622)
SAP # 4000011063
4SCJ32BTLLBL

deb
SKIN CARE

Principal Display Panel (946 mL Bottle Label)

Principal Display Panel (946 mL Bottle Label)

* Please review the disclaimer below.