CHLORA-CLEANZE- chlorhexidine gluconate and isopropyl alcohol swab 
Biotronix Healthcare Industries, Inc.

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.

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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

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

Directions

procedures.

minutes for moist sites)

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.

image of bottle label

image of bottle label

CHLORA-CLEANZE 
chlorhexidine gluconate and isopropyl alcohol swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71389-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71389-001-021.5 mL in 1 POUCH; Type 0: Not a Combination Product04/18/2017
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/FEIBusiness Operations
Longood Medicine (Beijing) Co., Ltd.529553064manufacture(71389-001)

Revised: 7/2017
Document Id: 54488be4-6181-5795-e054-00144ff88e88
Set id: 4de58778-9aad-54f0-e054-00144ff8d46c
Version: 2
Effective Time: 20170714
 
Biotronix Healthcare Industries, Inc.