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  5. Label Information: Provon Antimicrobial Foam Handwash

FDA Label for Provon Antimicrobial Foam Handwash

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. RECENT MAJOR CHANGES
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Provon Antimicrobial Foam Handwash 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.

Active Ingredient



chlorhexidine gluconate 2% solution


Purpose



Antiseptic


Uses



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

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.

    • Healthcare personnel handwash:

    • wet hands with water
    • dispense 5 mL of product (6 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds and rinse under running water and dry thoroughly

      • Surgical hand scrub:

      • wet hands and forearms with water
      • scrub for 3 minutes with 5 mL of product (6 full stokes), with a wet brush, paying close attention to the nails, cuticles, and skin between the fingers
      • a seperate nail cleaner may be used
      • rinse thoroughly
      • wash for an additional 3 minutes with 5 mL of product (6 full strokes) and rinse under running water and 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



PROVON® Antimicrobial Foam Handwash

Chlorhexidine Gluconate 2% Solution - Antiseptic

GOJOADXFLBLC

8842-643-F

8842

NDC 21749-850-90

Brought to you by GOJO

PROVON ®

Antimicrobial Foam Handwash with 2% CHG

Chlorhexidine Gluconate 2% Solution - Antiseptic

42 fl oz (1250 mL)

GOJOADXBLBLB

8842-642-B

PROVON ® Antimicrobial Foam Handwash

Chlorhexidine Gluconate 2% Solution - Antiseptic

GOJOLTXFLBLC

1922-643-F

.

1922

NDC 21749-850-89

Brought to you by GOJO

PROVON ®

Antimicrobial Foam Handwash with 2% CHG

Chlorhexidine Gluconate 2% Solution - Antiseptic

40.5 fl oz (1200 mL)

GOJOLTXBLBLB

1922-642-B


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