1. Home
  2. Labeler Index
  3. Xttrium Laboratories, Inc.
  4. 0116-0506
  5. Label Information: Bd E-z Scrub

FDA Label for Bd E-z Scrub

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. OTC - STOP USE
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. SURGICAL HAND SCRUB:
    12. HEALTHCARE PERSONNEL HANDWASH:
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. OTHER SAFETY INFORMATION
    17. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bd E-z Scrub Product Label

The following document was submitted to the FDA by the labeler of this product Xttrium Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.