KANK-A MOUTH PAIN- benzocaine liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)

Available from:

Blistex Inc.

Administration route:

BUCCAL

Prescription type:

OTC DRUG

Therapeutic indications:

Oral anesthetic/analgesic - for the temporary relief of pain due to canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums

Authorization status:

OTC monograph final

Summary of Product characteristics

KANK-A MOUTH PAIN- BENZOCAINE LIQUID
BLISTEX 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._
----------
KANK-A
MOUTH PAIN LIQUID
_DRUG FACTS_
ACTIVE INGREDIENT
Benzocaine 20.0% (w/w)
PURPOS E
Oral anesthetic/analgesic
US ES
for the temporary relief of pain due to canker sores, minor irritation
of the mouth and gums caused
by dentures or orthodontic appliances, or minor injury of the mouth or
gums
WARNINGS
METHEMOGLOBINEMIA WARNING
Use of this product may cause methemoglobinemia, a serious condition
that must be treated promptly
because it reduces the amount of oxygen carried in blood. Stop use and
seek immediate medical
attention if you or a child in your care develops:
pale, gray, or blue colored skin (cyanosis)
headache
rapid heart rate
shortness of breath
dizziness or lightheadedness
fatigue or lack of energy
ALLERGY ALERT
do not use this product if you have a history of allergy to local
anesthetics such as procaine, butacaine,
benzocaine, or other "caine" anesthetics.
DO NOT USE
for teething
in children under 2 years of age
WHEN USING THIS PRODUCT
do not use this product for more than 7 days unless directed by a
dentist or doctor. If sore mouth
symptoms do not improve in 7 days; if irritation, pain, or redness
persists or worsens; or if swelling,
rash or fever develops, see your doctor or dentist promptly.
do not exceed recommended dosage.
KEEP OUT OF REACH OF CHILDREN. If more than used for pain is
accidentally swallowed, get medical help
®
KEEP OUT OF REACH OF CHILDREN. If more than used for pain is
accidentally swallowed, get medical help
or contact a Poison Control Center right away.
DIRECTIONS
adults and children 2 years of age and older:
to assure formation of a long-lasting film coating, dry affected area
and apply medication
undiluted with applicator
allow a few seconds for coating to form
use up to 4 times daily, or as directed by a dent