Bactoshield Chg Solution
FDA Label NDC 0116-1344

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Xttrium Laboratories, Inc. for the product Bactoshield Chg (NDC 0116-1344). 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, purposes, uses, warnings, do not use, when using this product, otc - stop use, 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

Purposes

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

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

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

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 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)
  • void excessive heat above 40°C (104°F)

Questions Or Comments?

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