FDA.reportPublic FDA data

CHLORA-CLEANZE

Manufacturer
Biotronix Healthcare Industries, Inc. | US MED PHARM SUPPLIES, INC. | Longood Medicine (Beijing) Co., Ltd.
Effective date
2017-07-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:51:49

Label at a glance#

ProductCHLORA-CLEANZE
Active ingredientISOPROPYL ALCOHOL, CHLORHEXIDINE GLUCONATE
Label structure10 sections

Storage and handling

Other information ■ store between 15–30 °C (59–86 °F) ■ avoid freezing and excessive heat above 40 °C (104 °F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v

OTC - PURPOSE SECTION

Purposes
Antiseptic

WARNINGS SECTION

Warnings
For external use only. Flammable keep away from fire or flame.

  • do not use with electrocautery procedures

Do not use

  • On patients with allergies to Chlorhexidine gluconate or Isopropyl alcohol
  • As a general skin cleanser or on open wounds

OTC - STOP USE SECTION

Stop use immediately if irritation or allergic reaction occurs. Contact your doctor immediately!

DOSAGE & ADMINISTRATION SECTION

Directions

  • The maximum treatment area is 2.5” x 2.5”
  • Point directional arrow downward
  • Hold applicator at both ends firmly and with a flexible firm motion break center seal at perforations.
  • Remove side of applicator case with applicator tip and discard other side according to institutional

procedures.

  • Apply solution to site using lateral stokes in both directions. (30 seconds for dry sites and 2

minutes for moist sites)

  • Allow area to dry sufficiently. Dry sites for 30 seconds and moist areas for 1 minute.
  • Single use only. Discard remaining solution. Entire solution is not required to be used

INACTIVE INGREDIENT SECTION

Inactive ingredients USP purified water

INDICATIONS & USAGE SECTION

Use prior to surgery to prepare patient’s skin. Helps in the reduction of potentially harmful bacteria which can cause skin infections.

STORAGE AND HANDLING SECTION


Other information
■ store between 15–30 °C (59–86 °F)
■ avoid freezing and excessive heat above 40 °C (104 °F)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children contact Poison Control or get medical help immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of pouch labelimage of pouch label

image of pouch labelimage of pouch label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1918214chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Medicated PadPSN2
1918214chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated PadSCD2
1918214chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Medicated PadSY2
1918214chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical SwabSY2

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
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71389-001-012022-01-28C16284748780-1d6a99b39-8281-a426-e053-dadaa90af4c24de49446-71ba-372a-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71389-001-01CHLORA-CLEANZE0.67 mL in 1 POUCHSWAB0.672

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71389-001CHLORA-CLEANZE (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SWAB [BIOTRONIX HEALTHCARE INDUSTRIES, INC.]2Legacy NDC, 1 package rows20170705_4de49446-71ba-372a-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71389-00171389-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EACTIB

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
5393c5bd-e575-63c1-e054-00144ff8d46c4de49446-71ba-372a-e054-00144ff8d46c2017-07-05WarningsExact identifier
spl id: 5393c5bd-e575-63c1-e054-00144ff8d46c
spl set id: 4de49446-71ba-372a-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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