KANKA SOFTBRUSH- benzocaine and zinc chloride gel

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Kupi sada

Preuzimanje Svojstava lijeka (SPC)
26-11-2018

Aktivni sastojci:

Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5), Zinc Chloride (UNII: 86Q357L16B) (Zinc cation - UNII:13S1S8SF37)

Dostupno od:

Blistex Inc.

Administracija rute:

ORAL

Tip recepta:

OTC DRUG

Terapijske indikacije:

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

Status autorizacije:

OTC monograph not final

Svojstava lijeka

                                KANKA SOFTBRUSH- BENZOCAINE AND ZINC CHLORIDE GEL
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._
----------
BLIS TEX KANKA SOFTBRUSH
TOOTH & GUM PAIN GEL
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSE_
Benzocaine 20.0% (w/w)
Oral anesthetic/analgesic
Zinc Chloride 0.1% (w/w)
Oral astringent
US ES
for the temporary relief of pain due to toothaches, 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 rare but 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
FOR ORAL USE ONLY
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.
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
or contact a Poison Control
Center right away.
DIRECTIONS
®
®
®
twist base clockwise to dispense. It may take up to 10 full turns to
dispense the initial dose, but
subsequent uses should require less than 1 turn.
to clean brush tip, rinse with cold water
adults and children 2 years of age and older: dry affected area and
apply medication by gently
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