CHLORA-CLEANZE- chlorhexidine gluconate and isopropyl alcohol swab

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302), CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)

Available from:

Biotronix Healthcare Industries, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purposes Antiseptic Stop use immediately if irritation or allergic reaction occurs. Contact your doctor immediately! Use prior to surgery to prepare patient’s skin. Helps in the reduction of potentially harmful bacteria which can cause skin infections.

Authorization status:

OTC monograph not final

Summary of Product characteristics

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 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 T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:7138 9 -0 0 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ISO PRO PYL ALCO HO L (UNII: ND2M4