BETASEPT- antiseptic surgical scrub solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L)

Available from:

Atlantis Consumer Healthcare, Inc.

INN (International Name):

Chlorhexidine Gluconate

Composition:

Chlorhexidine Gluconate .04 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Antiseptic Do not use - if you or the patient is allergic to chlorhexidine gluconateor any other ingredient in this product - in contact with meninges - in the genital area Stop use and ask a doctor if irritation,sensitization, or allergic reaction occurs. These may be signs ofa serious condition. Surgical hand scrub: - wet hands and forearms with water - scrub for 3 minutes with about 5 mL of product and a wetbrush, paying close attention to the nails, cuticles, and interdigitalspaces - a separate nail cleaner may be used - rinse thoroughly - wash for an additional 3 minutes with 5 mL of product andrinse under running water - dry thoroughly

Authorization status:

New Drug Application

Summary of Product characteristics

BETASEPT- ANTISEPTIC SURGICAL SCRUB SOLUTION
ATLANTIS CONSUMER HEALTHCARE, INC.
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BETASEPT ANTISEPTIC SURGICAL SCRUB
CHLORHEXIDINE GLUCONATE 4%
_DRUG FACTS_
_ACTIVE INGREDIENT PURPOSE_
Chlorhexidine gluconate 4% solution
PURPOSE
Antiseptic
_USES_
SURGICAL HAND SCRUB: significantly reducesthe number of microorganisms
on the
hands and forearms prior to surgery or patient care
HEALTHCARE PERSONNEL HANDWASH: helps reducebacteria that potentially
can cause
disease
SKIN WOUND AND GENERAL SKIN CLEANSING
_WARNINGS_
FOR EXTERNAL USE ONLY
ALLERGY ALERT: This product may cause 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 gluconateor any
other ingredient in
this product
in contact with meninges
in the genital area
WHEN USING THIS PRODUCT
keep out of eyes, ears, and mouth. May cause serious andpermanent eye
injury if
permitted to enter and remain in the eye ormay cause deafness when
instilled in the
middle ear through perforatedeardrums.
if solution should contact these areas, rinse out promptlyand
thoroughly with water
wounds which involve more than the superficial layers ofthe skin
should not be
routinely treated
repeated general skin cleansing of large body areas shouldnot be done
except when
advised by a health care provider
STOP USE AND ASK A DOCTOR IF irritation,sensitization, or allergic
reaction occurs. These
may be signs ofa serious condition.
KEEP OUT OF REACH OF CHILDREN. Ifswallowed, get medical help or
contact a Poison
Control Center rightaway.
_DIRECTIONS_
use with care in premature infants or infants under 2 months of age.
These products
may cause irritation or chemical burns.
SURGICAL HAND SCRUB:
wet hands and forearms with water
scrub for 3 minutes with about 5 mL of product and a wetbrush, paying
close
attention to the nails, cuticles, and interdigitalspaces
a separate nail cleaner may be used
rin