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Provon Antimicrobial Foam Handwash

Chlorhexidine Gluconate 2% · Solution

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Provon Antimicrobial Foam Handwash
Generic name
Chlorhexidine Gluconate 2%
Dosage form
Solution
Route
Topical
Marketing category
NDA · NDA
Labeler
Gojo Industries, Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
5
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Chlorhexidine Gluconate 20 mg/mL 1667684 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Topical
Presentations
7

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Decreased Cell Wall Integrity [PE] PE All 26 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
019422
Application type
NDA · New Drug Application
Approval date
December 17, 1985
Sponsor
XTTRIUM
Products on application
1
Submissions recorded
35
Products approved under application 019422.
Product Trade name Form Strength Ingredient Status TE Flags
019422-001 DYNA-HEX 2 SOLUTION CHLORHEXIDINE GLUCONATE Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 019422.
Type No. Action Status Date Review
Supplement 56 Labeling Approved July 25, 2026 Standard
Supplement 55 Labeling Approved February 3, 2026 Standard
Supplement 49 Manufacturing (CMC) Approved January 25, 2019 Standard
Supplement 47 Labeling Approved September 15, 2017 Standard
Supplement 46 Manufacturing (CMC) Approved April 11, 2016 Standard
Supplement 45 Manufacturing (CMC) Approved March 24, 2016 Standard
Supplement 43 Labeling Approved December 12, 2012 Standard
Supplement 37 Manufacturing (CMC) Approved February 25, 2009 N/A
Supplement 36 Manufacturing (CMC) Approved February 25, 2009 N/A
Supplement 33 Manufacturing (CMC) Approved December 20, 2004 Standard
Supplement 32 Efficacy Approved December 19, 2003 Standard
Supplement 28 Manufacturing (CMC) Approved March 29, 2000 Standard
Supplement 29 Manufacturing (CMC) Approved October 8, 1999 Standard
Supplement 27 Manufacturing (CMC) Approved October 19, 1998 Standard
Supplement 26 Manufacturing (CMC) Approved September 30, 1998 Standard
Supplement 25 Manufacturing (CMC) Approved January 8, 1998 Standard
Supplement 24 Manufacturing (CMC) Approved April 17, 1997 Standard
Supplement 23 Manufacturing (CMC) Approved March 11, 1997 Standard
Supplement 22 Manufacturing (CMC) Approved May 6, 1996 Standard
Supplement 21 Manufacturing (CMC) Approved April 3, 1996 Standard
Supplement 20 Manufacturing (CMC) Approved February 12, 1996 Standard
Supplement 19 Manufacturing (CMC) Approved February 6, 1996 Standard
Supplement 18 Manufacturing (CMC) Approved February 6, 1996 Standard
Supplement 17 Manufacturing (CMC) Approved May 10, 1995 Standard
Supplement 16 Manufacturing (CMC) Approved May 10, 1995 Standard
Supplement 15 Manufacturing (CMC) Approved November 6, 1992 Standard
Supplement 1 Efficacy Approved December 27, 1989 —
Supplement 9 Manufacturing (CMC) Approved July 28, 1989 Standard
Supplement 7 Manufacturing (CMC) Approved August 12, 1988 Standard
Supplement 6 Manufacturing (CMC) Approved June 28, 1988 Standard
Supplement 5 Manufacturing (CMC) Approved April 12, 1988 Standard
Supplement 2 Manufacturing (CMC) Approved March 2, 1988 Standard
Supplement 4 Manufacturing (CMC) Approved September 16, 1987 Standard
Supplement 3 Manufacturing (CMC) Approved September 16, 1987 Standard
Original application 1 Type 3 - New Dosage Form Approved December 17, 1985 Standard

Review documents

  • 0 · Supplement · July 28, 2026
  • 0 · Supplement · July 27, 2026
  • 0 · Supplement · February 5, 2026
  • 0 · Supplement · February 5, 2026
  • 0 · Supplement · February 13, 2019
  • 0 · Supplement · February 6, 2019
  • 0 · Supplement · September 19, 2017
  • 0 · Supplement · January 14, 2014
  • 0 · Supplement · December 18, 2012
  • 0 · Supplement · February 27, 2009
  • 0 · Supplement · February 27, 2009
  • 0 · Supplement · July 9, 2007
  • 0 · Supplement · December 30, 2004
  • 0 · Supplement · December 23, 2003

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250430). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250430 HUMAN OTC DRUG · 20221220 HUMAN OTC DRUG · 20190619

Recent Major Changes

openFDA Drug Labeling

Indications and Usage Dosage and Administration

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Purpose surgical hand scrub healthcare personnel handwash

Dosage and Administration

openFDA Drug Labeling

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 product (6 full strokes), with a wet brush, paying close attention to the nails, cuticles, and skin between the fingers a separate 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 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

Warnings

openFDA Drug Labeling

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

Do Not Use

openFDA Drug Labeling

Do not use if you are allergic to chlorhexidine gluconate or any other ingredient in this product

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

Active Ingredient

openFDA Drug Labeling

Active ingredient chlorhexidine gluconate 2% solution

Adverse event reports

Source: openFDA FAERS
9,457
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: CHLORHEXIDINE GLUCONATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
21749-850-53 21749-850 Gojo Industries, Inc. 535 mL in 1 BOTTLE (21749-850-53) May 1, 2016
21749-850-89 21749-850 Gojo Industries, Inc. 1200 mL in 1 BOTTLE, DISPENSING (21749-850-89) July 1, 2016
21749-850-90 21749-850 Gojo Industries, Inc. 1250 mL in 1 BOTTLE, DISPENSING (21749-850-90) July 1, 2016
0116-8500-89 0116-8500 Xttrium Laboratories, Inc. 1200 mL in 1 BOTTLE, DISPENSING (0116-8500-89) July 1, 2016
0116-8500-90 0116-8500 Xttrium Laboratories, Inc. 1250 mL in 1 BOTTLE, DISPENSING (0116-8500-90) July 1, 2016
21749-850 21749-850 Gojo Industries, Inc. — May 1, 2016
0116-8500 0116-8500 Xttrium Laboratories, Inc. — July 1, 2016

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.