BENCOCAINE TOPICAL ANESTHETIC- benzocaine gel

BencoCaine Topical Anesthetic by

Drug Labeling and Warnings

BencoCaine Topical Anesthetic by is a Otc medication manufactured, distributed, or labeled by Benco Dental. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Benzocaine 200 mg (in each g)

Purpose

Oral Anesthetic

INDICATIONS & USAGE

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

Warnings

Warnings
Methemoglolllnemla
warning: Use of this product
may cause methemoglobinemia,
a seriouscondit~n that must be
treated promptly because tt
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

Allergy Alert Do not use on
patients with a history of
allergies to local anesthetics
suchasprocaine,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 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).
Protect from freezing.

Inactive Ingredients

flavoring, PEG 3350, PEG 400, sodium saccharin.

Questions or Comments?

800.GO.BENCO or benco.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENCOCAINE TOPICAL ANESTHETIC 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66975-341
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Product Characteristics
Color	white (DYE-FREE)	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66975-341-30	30 g in 1 JAR; Type 0: Not a Combination Product	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/01/2020

Labeler - Benco Dental (015108087)