Bd E-z Scrub
FDA Label NDC 0116-0506

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 Bd E-z Scrub (NDC 0116-0506). 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, 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.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

chlorhexidine gluconate 2% solution

Purpose

surgical hand scrub

healthcare personnel handwash

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

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 are allergic to chlorhexidine gluconate or any other ingredient in this product

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
  • do not use routinely if you have wounds which involve more than the superficial layers of the skin

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 5 ml of solution (4 full strokes) and a wet brush paying close attention to the nails, cuticles, and interdigital space
  • a separate nail cleaner may be used
  • rinse thoroughly
  • wash for an additional 3 minutes with 5 ml of solution (4 full strokes) and rinse under running water
  • dry thoroughly

Healthcare Personnel Handwash:

  • wet hands with water
  • dispense 5 ml of solution (4 full strokes) into cupped hands, wash in a vigorous manner for 15 seconds, and rinse under running water
  • dry thoroughly

Other Information

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

Inactive Ingredients

citric add. cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Package Label.Principal Display Panel

NDC 17271-506-02

BD E-Z Scrub

Chlorhexidine Gluconate 2% Solution Antiseptic

REF 372416

Foreign Patents and Pantents Pending

U.S. Patent 6,427,875

Chlorhexidine Gluconate

32 fl oz (946 mL)

2bd32sq (2bd32sq)

2bd32sq (2bd32sq)

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