FDA Label for Chlora-cleanze
View Indications, Usage & Precautions
Chlora-cleanze Product Label
The following document was submitted to the FDA by the labeler of this product Biotronix Healthcare Industries, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients
Chlorhexidine gluconate 2% w/v
Isopropyl alcohol 70% v/v
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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