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  5. Label Information: Bd E-z Scrub 107

FDA Label for Bd E-z Scrub 107

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USE
    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. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bd E-z Scrub 107 Product Label

The following document was submitted to the FDA by the labeler of this product Becton Dickinson And Company. 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



4% Chlorhexidine gluconate w/v


Purpose



Antiseptic


Use



preoperative cleaning of healthcare personnel arms and hands.


Warnings



For external use only.


Do Not Use



  • as a preoperative skin preparation of the face or head
  • in eyes, ears and mouth
  • if you have a sensitivity to chlorhexidine gluconate or its components.

When Using This Product



  • avoid contact with meninges
  • chlorhexidine gluconate has been reported to cause deafness when instilled in the middle ear through perforated ear drums
  • chlorhexidine gluconate solution has been reported to cause serious and permanent eye injury when it has been permitted to enter and remain in the eye during surgical procedures
  • if chlorhexidine gluconate solution should contact these areas, rinse out promptly and thoroughly with water.

Otc - Stop Use



Stop use and ask a doctor if adverse reactions occur. Irritation, sensitization and generalized allergic reactions have been reported with chlorhexidine-containing products, especially in the genital areas.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, gets in eye or ear, get medical help or contact a Poison Control Center immediately.


Directions



  • wet hands and forearms to the elbows with warm water
  • use nail cleaner and apply scrub solution from sponge side
  • work up lather
  • scrub nails, cuticles and interdigital spaces thoroughly for 3 minutes with brush side and hands and forearms with the sponge side
  • rinse with warm water
  • repeat scrub for 3 more minutes, use the sponge side only. Add water as necessary to produce the desired level of suds.
  • rinse hands and arms thoroughly
  • dry thoroughly

Other Information



  • avoid excessive heat 40°C (104°F)
  • discard after single use.

Inactive Ingredients



FD&C red #40, hydrochloric acid, lauramide DEA, nonoxynol-12, peg-6000 distearate, peg-75 lanolin, purified water USP, sodium hydroxide


Package Label.Principal Display Panel



Principal Display Panel – Carton Label

BD
BD E-Z Scrub™ 107
Surgical Scrub Brush/Sponge
and Nail Cleaner with
4% Chlorhexidine Gluconate

4% CHG
CONTAINS:
30

NOTE: SEE BACK PANEL
FOR EASY INSTRUCTIONS

REF 371073
NDC 17271-107-03
U.S. Patent 5, 164, 107

Principal Display Panel – Package Label

BD E-Z Scrub™ 107
Surgical Scrub Brush/Sponge
4% CHG
NDC 17271-107-03
REF 371073


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