Otc - Active Ingredient
Active ingredients
Chlorhexidine gluconate 2% w/v
Isopropyl alcohol 70% v/v
Chlora-cleanze
FDA Label NDC 71389-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biotronix Healthcare Industries, Inc. for the product Chlora-cleanze (NDC 71389-001). 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 otc - active ingredient, otc - purpose, warnings, otc - stop use, dosage & administration, inactive ingredient, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purposes
Antiseptic
Warnings
Warnings
For external use only. Flammable keep away from fire or flame.
- do not use with electrocautery procedures
- On patients with allergies to Chlorhexidine gluconate or Isopropyl alcohol
- As a general skin cleanser or on open wounds
Do not use
Otc - Stop Use
Stop use immediately if irritation or allergic reaction occurs. Contact your doctor immediately!
Dosage & Administration
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
- Apply solution to site using lateral stokes in both directions. (30 seconds for dry sites and 2
- 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
procedures.
minutes for moist sites)
Inactive Ingredient
Inactive ingredients USP purified water
Indications & Usage
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
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
Keep out of reach of children contact Poison Control or get medical help immediately.
Package Label.Principal Display Panel
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