Maxiclens Chlorhexidine gluconate Liquid Solution, 4%

Manufacturer
Henry Schein, Inc.
Effective date
2023-02-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:20

Label at a glance#

ProductMaxiclens Chlorhexidine gluconate Liquid Solution, 4%
Active ingredientCHLORHEXIDINE GLUCONATE
Label structure13 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Chlorhexidine gluconate solution, 4%

OTC - PURPOSE SECTION

Purposes

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

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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 procedures or may cause deafness when instilled in the middle ear through perforated eardrums.
  • 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 an underlying condition makes it necessary to reduce the bacterial population of the skin

OTC - STOP USE SECTION

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 SECTION

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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 SECTION

Inactive ingredients

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

*contains one or more of these ingredients

OTC - QUESTIONS SECTION

Questions or comments?

aaCall 1-800-581-2528 Monday through Friday 8:00 AM to 5:00 PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0404-0175-02

Maxiclens TM

Antiseptic Skin Cleanser

(Chlorhexidine Gluconate 4%)

FOR EXTERNAL USE ONLY

Distributed By

HENRY SCHEIN INC.

135 Duryea Road

Melville, NY 11747 USA

Net Contents

32 fl oz (1 qt)(946-mL)

Made in U.S.A.

Product Made in U.S.A.
Keep from freezing.

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers
will cause stains if used with chlorine releasing products, such as chlorine
bleach. Rinse completely and use only non-chlorine detergents.

bbWARNING: This product can expose you to coconut oil diethanolamine condensate
(cocamide diethanolamine), which is known to the State of California to cause
cancer. For more information go to www.P65Warnings.ca.gov

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSN1
2630838Maxiclens 4 % Medicated Liquid SoapPSN1
2630838chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Maxiclens]SBD1
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD1
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSY1
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSY1
2630838Maxiclens 4 % Medicated Surgical ScrubSY1
2630838Maxiclens 40 MG/ML Medicated Surgical ScrubSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0404-0175-022026-01-29C16284748780-149896155-a4c3-586f-e063-e6dba90add90f5cf0e60-9e0a-75b0-e053-2a95a90aeba3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0175-02Maxiclens Chlorhexidine gluconate Liquid Solution, 4%946 mL in 1 BOTTLESOLUTION9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-0175MAXICLENS CHLORHEXIDINE GLUCONATE LIQUID SOLUTION, 4% (CHLORHEXIDINE GLUCONATE) SOLUTION [HENRY SCHEIN, INC.]11 package rows20230302_f5cf0e60-9e0a-75b0-e053-2a95a90aeba3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0404-01750404-0175-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f5cf0e60-9e0b-75b0-e053-2a95a90aeba3f5cf0e60-9e0a-75b0-e053-2a95a90aeba32023-02-28WarningsExact identifier
spl id: f5cf0e60-9e0b-75b0-e053-2a95a90aeba3
spl set id: f5cf0e60-9e0a-75b0-e053-2a95a90aeba3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.