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CHLORA-CLEANZE by Biotronix Healthcare Industries, Inc.

Dosage form: swab
Ingredients: ISOPROPYL ALCOHOL 0.7mL in 1mL, CHLORHEXIDINE GLUCONATE 20mg in 1mL
Labeler: Biotronix Healthcare Industries, Inc.
NDC Code: 71389-001

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v

Purposes
Antiseptic

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

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

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 ingredients USP purified water

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


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

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

CHLORA-CLEANZE 
chlorhexidine gluconate and isopropyl alcohol swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71389-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:71389-001-021.5 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/18/2017
Labeler - Biotronix Healthcare Industries, Inc. (065762392)
Registrant - US MED PHARM SUPPLIES, INC. (831533109)
Establishment
NameAddressID/FEIOperations
Longood Medicine (Beijing) Co., Ltd.529553064manufacture(71389-001)

Revised: 07/2017
 
Biotronix Healthcare Industries, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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