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  5. Label Information: Dr. Dean

FDA Label for Dr. Dean

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENT
    12. OTC - QUESTIONS
    13. REPRESENTATIVE LABEL AND PRINCIPAL DISPLAY PANEL

Dr. Dean Product Label

The following document was submitted to the FDA by the labeler of this product Usa Medical Supply Llc. 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.

Active Ingredient



Chlorhexidine gluconate solution, 2%


Purposes



Surgical hand scrub

Healthcare personnel handwash

Skin wound and general skin cleanser


Uses



  • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
  • healthcare personnel handwash: handwash to help reduce bacteria that potentially can cause disease
  • skin wound and general cleanser: helps reduce bacteria on the skin

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 ingredients in this preparation
  • as a properative skin preparation (especially on the head or face)
  • 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 placed or kept in the eye during surgical during surgical procedures or may cause deafness when instilled in the middle ear through perforated ear drums.
  • if contact occurs, rinse with cold water right away
  • 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 underlying condition makes it necessary to reduce the bacterial population of the skin

Stop Use And Ask A Doctor If



  • irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. 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 product may cause irritation or chemical burns.
  • use full strength
  • do not dilute

    • Surgical hand scrub

    • remove jewelry
    • wet hands and forearms with water and apply 5 mL of the product
    • wash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces
    • rinse thoroughly with water
    • washfor an additional 3 minutes with 5 mL of the 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 30 seconds
      • rinse and dry thoroughly

        • Skin wound and general skin cleanser

        • thoroughly rinse the area to be cleansed with water
        • apply the minimum amount of product necessary to cover the skin or wound area and wash gently. Rinse thoroughly with water.
        • rinse again thoroughly

Other Information



  • store between 20-25 °C (68-77 °F)
  • avoid excessive heat (above 104 °F/40 °C)
  • for additional information, see Safety Data Sheet (SDS)
  • if swallowed get medical help or contact a Poison Control Center immediately

Inactive Ingredient



Inactive ingredients cocamide DEA, cocamine oxide, fragrance, gluconic acid*, gluconolactone*, hydroxyethylcellulose, isopropyl alcohol 4%, PEG-75 lanolin, PEG-150 distearate, propylene glycol, quaternium-60, water

*contains one or more of these ingredients


Otc - Questions



Questions or comments? call 1.800.581.2528, 24 hours a day, 7 days a week


Representative Label And Principal Display Panel



Dr. Dean

Chlorhexidine Gluconate

Liquid Solution

2.0%

Up to 6 Hour Protection

Antimicrobial Skin Soap

FOR EXTERNAL USE ONLY

Distributed by USA Medical Supply

Northbrook IL 60062

www.usamdsupply.com

4 FL OZ (118 mL)

NDC 81657-002-01

MADE IN THE USA

FDA APPROVED

fourwht - wht4oz2chg

fourwht - wht4oz2chg

Dr. Dean

Chlorhexidine Gluconate

Liquid Solution

2.0%

Up to 6 Hour Protection

Antimicrobial Skin Soap

FOR EXTERNAL USE ONLY

Distributed by USA Medical Supply

Northbrook IL 60062

www.usamdsupply.com

8 FL OZ (236 mL)

NDC 81657-002-02

MADE IN THE USA

FDA APPROVED

Dr. Dean

Chlorhexidine Gluconate

Liquid Solution

2.0%

Up to 6 Hour Protection

Antimicrobial Skin Soap

FOR EXTERNAL USE ONLY

Distributed by USA Medical Supply

Northbrook IL 60062

www.usamdsupply.com

128 FL OZ (3785 mL)

NDC 81657-002-03

MADE IN THE USA

FDA APPROVED


* Please review the disclaimer below.