BENZOCAINE MINT- benzocaine gel BENZOCAINE BUBBLE GUM- benzocaine gel BENZOCAINE RASPBERRY- benzocaine gel BENZOCAINE PINA CO

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Benzocaine 200 mg (in each g)

Available from:

Darby Dental Supply, LLC

INN (International Name):

Benzocaine

Composition:

Benzocaine 220 mg in 1 g

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

Oral Anesthetic For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

Authorization status:

OTC monograph not final

Summary of Product characteristics

BENZOCAINE MINT- BENZOCAINE GEL
BENZOCAINE BUBBLE GUM- BENZOCAINE GEL
BENZOCAINE RASPBERRY- BENZOCAINE GEL
BENZOCAINE PINA COLADA- BENZOCAINE GEL
DARBY DENTAL SUPPLY, LLC
_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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20% BENZOCAINE GEL
DRUG FACTS
ACTIVE INGREDIENTS
Benzocaine 200 mg _(IN EACH G)_
PURPOSE
Oral Anesthetic
USE
For oral mucosal use only, as directed by dentist. For the temporary
relief of pain due to
minor dental procedures.
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
the 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 on patients with a history of allergies to local
anesthetics such as procaine,
butacaine, benzocaine or other "caine" anesthetics.
DO NOT USE
for more than 7 days unless directed by a physician. If sore mouth
symptoms do not
improve in 7 days; irritation, pain, or redness persists or worsens;
or if swelling, rash
or fever develops, see your physician promptly.
for teething
in children under 2 years of age
WHEN USING THIS PRODUCT
Avoid contact with eyes. If contact occurs, flush with water.
DO NOT EXCEED RECOMMENDED DOSAGE. If more than used for pain is
accidentally
swallowed, get medical help or contact a Poison Control Center right
away.
IF PREGNANT OR BREAST FEEDING, ask a physician before use.
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
Apply only amount needed to the oral mucosa to prevent or relieve
pain.
children under 2 years of age: do not use
OTHER INFORMATION
Store at 59° - 86°F (15 - 30°C). Prote