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Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%

Chlorhexidine Gluconate · Solution

Over-the-counter NDA 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
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%
Generic name
Chlorhexidine Gluconate
Dosage form
Solution
Route
Topical
Marketing category
NDA · NDA
Labeler
Henry Schein, Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
3
Packages
3
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 40 mg/mL 1667684 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Topical
Presentations
6

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
019258
Application type
NDA · New Drug Application
Approval date
July 22, 1986
Sponsor
ECOLAB
Products on application
2
Submissions recorded
18
Products approved under application 019258.
Product Trade name Form Strength Ingredient Status TE Flags
019258-001 CIDA-STAT SOLUTION CHLORHEXIDINE GLUCONATE Over-the-counter —
019258-002 CHG SCRUB SOLUTION CHLORHEXIDINE GLUCONATE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 019258.
Type No. Action Status Date Review
Supplement 26 Labeling Approved January 10, 2018 Standard
Supplement 23 Manufacturing (CMC) Approved January 14, 2016 Standard
Supplement 22 Manufacturing (CMC) Approved December 28, 2015 Standard
Supplement 21 Manufacturing (CMC) Approved August 5, 2015 Standard
Supplement 20 Manufacturing (CMC) Approved December 16, 2014 Standard
Supplement 19 Labeling Approved May 17, 2012 Standard
Supplement 16 Labeling Approved April 23, 2010 Standard
Supplement 14 Manufacturing (CMC) Approved April 3, 2006 Standard
Supplement 11 Manufacturing (CMC) Approved February 15, 2005 Standard
Supplement 13 Manufacturing (CMC) Approved December 20, 2002 Standard
Supplement 12 Manufacturing (CMC) Approved July 25, 2002 Standard
Supplement 10 Manufacturing (CMC) Approved April 17, 2001 Standard
Supplement 8 Labeling Approved December 8, 1995 Standard
Supplement 9 Manufacturing (CMC) Approved August 16, 1995 Standard
Supplement 6 Manufacturing (CMC) Approved May 10, 1993 Standard
Supplement 7 Manufacturing (CMC) Approved May 6, 1993 Standard
Supplement 2 Manufacturing (CMC) Approved June 2, 1987 Standard
Original application 1 Type 5 - New Formulation or New Manufacturer Approved July 22, 1986 Standard

Review documents

  • 0 · Supplement · January 17, 2018
  • 0 · Supplement · January 11, 2018
  • 0 · Supplement · January 15, 2016
  • 0 · Supplement · January 15, 2016
  • 0 · Supplement · August 10, 2015
  • 0 · Supplement · May 21, 2012
  • 0 · Supplement · April 28, 2010
  • 0 · Supplement · April 7, 2006
  • 0 · Supplement · February 17, 2005

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260217). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260217

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: handwash to help reduce bacteria that potentially can cause disease skin wound and general skin cleanser: helps reduce bacteria on the skin

Purpose

openFDA Drug Labeling

Purposes Surgical hand scrub Healthcare personnel handwash Skin wound and general skin cleanser

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. 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 wash for 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

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

openFDA Drug Labeling

Do not use if you are allergic to chlorhexidine gluconate or any other ingredient in this preparation as a patient preoperative skin preparation (especially on the head or face) in contact with meninges in the genital area

Stop Use

openFDA Drug Labeling

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.

Active Ingredient

openFDA Drug Labeling

Active ingredient Chlorhexidine gluconate solution, 4%

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
0404-0219-01 0404-0219 Henry Schein, Inc. 118 mL in 1 BOTTLE (0404-0219-01) November 17, 2021
0404-0220-03 0404-0220 Henry Schein, Inc. 236 mL in 1 BOTTLE (0404-0220-03) November 17, 2021
0404-0221-04 0404-0221 Henry Schein, Inc. 473 mL in 1 BOTTLE (0404-0221-04) November 17, 2021
0404-0219 0404-0219 Henry Schein, Inc. — November 17, 2021
0404-0220 0404-0220 Henry Schein, Inc. — November 17, 2021
0404-0221 0404-0221 Henry Schein, Inc. — November 17, 2021

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 · 10 sections on this page.