Provon Antimicrobial Foam Handwash Solution
FDA Label NDC 0116-8500

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 Provon Antimicrobial Foam Handwash (NDC 0116-8500). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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