CHLORA-CLEANZE- chlorhexidine gluconate and isopropyl alcohol swab

CHLORA-CLEANZE by

Drug Labeling and Warnings

CHLORA-CLEANZE by is a Otc medication manufactured, distributed, or labeled by Biotronix Healthcare Industries, Inc., US MED PHARM SUPPLIES, INC., Longood Medicine (Beijing) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v

PURPOSE

Purposes
Antiseptic

WARNINGS

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

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

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

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)

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHLORA-CLEANZE 
chlorhexidine gluconate and isopropyl alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71389-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL  in 1 mL
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71389-001-02	1.5 mL in 1 POUCH; Type 0: Not a Combination Product	04/18/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/18/2017

Labeler - Biotronix Healthcare Industries, Inc. (065762392)

Registrant - US MED PHARM SUPPLIES, INC. (831533109)

Establishment
Name	Address	ID/FEI	Business Operations
Longood Medicine (Beijing) Co., Ltd.		529553064	manufacture(71389-001)