IODENT ORAL ANALGESIC- benzocaine gel

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)

Dostupné z:

United Exchange Corp.

Spôsob podávania:

TOPICAL

Typ predpisu:

OTC DRUG

Terapeutické indikácie:

Uses for the temporary relief of pain due to: - toothache - canker sores - gum pain - denture pain - cheek bites Do not use - more than directed - for more than 7 days unless directed by a doctor - for teething - in children under 2 years of age Stop use and ask a doctor if - sore mouth symptoms do not improve in 7 days - irritation, pain or redness does not go away - swelling, rash or fever develops Directions

Stav Autorizácia:

OTC monograph not final

Súhrn charakteristických

IODENT ORAL ANALGESIC- BENZOCAINE GEL
UNITED EXCHANGE CORP.
_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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IODENT ORAL ANALGESIC GEL 0.42 OZ 490 (ZDP)
Active ingredient Purpose
Benzocaine 20%............................................Oral Pain
Reliever
Uses
for the temporary relief of pain due to:
toothache
canker sores
gum pain
denture pain
cheek bites
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. This can occur even if you have used this
product before. 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 your child has a history of
allergy or local
anesthetics such as procaine, butacaine, benzocaine or other "caine"
anesthetics.
Do not use
more than directed
for more than 7 days unless directed by a doctor
for teething
in children under 2 years of age
Stop use and ask a doctor if
sore mouth symptoms do not improve in 7 days
irritation, pain or redness does not go away
swelling, rash or fever develops
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
Keep out of reach of children:
If swallowed, get medical help or contact a Poison Control Center
(1-800-222-1222)
right away.
Directions
Adults and
children 2 years
of age and older.
Remove cap and cut tip of tube. Apply a small amount of product to
the cavity and around gum surrounding the teeth. Use up to 4 times
daily or as directed by a dentist or doctor.
Children under
12 years of age.
Should be supervised in the use of this product.
Children under 2
years of age.
Do not use.
Other information
store at room t