HIBICLENS- chlorhexidine gluconate 4% solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)

Available from:

Xttrium Laboratories, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic - antimicrobial skin cleanser helps reduce bacteria that potentially can cause disease - for skin wound and general skin cleansing - surgical hand scrub - healthcare personnel handwash irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Authorization status:

New Drug Application

Summary of Product characteristics

HIBICLENS- CHLORHEXIDINE GLUCONATE 4% SOLUTION
XTTRIUM LABORATORIES, INC.
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HIBICLENS 4% CHG 4OZ FOAMER (IFP)
ACTIVE INGREDIENT
Chlorhexidine gluconate solution 4.0% w/v
PURPOSE
Antiseptic
USES
antimicrobial skin cleanser helps reduce bacteria that potentially can
cause disease
for skin wound and general skin cleansing
surgical hand scrub
healthcare personnel handwash
WARNINGS
For external use only
ALLERGY ALERT
This product may cuase a severe allergic reaction. Symptoms may
include:
wheezing/difficulty breathing
shock
facial swelling
hives
rash
If an allergic reaction occurs, stop use and seek medical help right
away.
DO NOT USE
if you or the patient is allergic to chlorhexidine gluconate or any
other ingredient in
this product
in contact with the meninges
in the genital area
WHEN USING THIS PRODUCT
keep out of eyes, ears, and mouth. May cause serious and permanent eye
injury if
permitted to enter and remain in the eye or may cause deafness when
instilled in the
middle ear through perforated eardrums.
if contact occurs in any of these areas, rinse with cold water right
away
wounds which involve more than the superficial layers of the skin
should not be
routinely treated
repeated general cleansing of large body areas should not be done
except when
advised by a health care provider
STOP USE AND ASK DOCTOR IF
irritation, sensitization, or allergic reaction occurs. These may be
signs of a serious
condition.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
use with care in premature infants or infants under 2 months of age.
These products
may cause irritation or chemical burns.
skin wound and general skin cleansing.
Thoroughly rinse the area to be cleansed with water. Apply the minimum
amount of the
product necessary to cover the skin or wound area and wash gently.
Rinse thoroughly.
surgical hand scrub.
Wet hands and forearms with water. Scrub for 3 minutes with about 5 mL
(4 pumps) of
the product with a brush. Rinse thoroughly under running water.
Repeat. Dry
thorough