SPL v2
SPL
SPL Set ID 05e31aaa-a934-f48b-e063-6394a90af32e
Route
DENTAL
Published
Effective Date 2020-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Polyethylene Glycol 3350 Saccharin Sodium Polyethylene Glycol 400

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-01

Description

Benzocaine 200 mg (in each g)

Purpose

Oral Anesthetic


Medication Information

Indications and Usage

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

Purpose

Oral Anesthetic

Description

Benzocaine 200 mg (in each g)

Section 51945-4

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

Directions

• Apply only amount needed to

the oral mucosa to prevent or

relieve pain.

• children under 2 years of age:

do not use

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

Allergy Alert

Allergy Alert Do not use on

patients with a history of

allergies to local anesthetics

suchasprocaine,butacaine,

benzocaine or other "caine"

anesthetics.

Other Information

Store at 59 -86°F(15-30°C).

Protect from freezing.

Active Ingredients

Benzocaine 200 mg (in each g)

Inactive Ingredients

flavoring, PEG 3350, PEG 400, sodium saccharin.

Questions Or Comments?

800.GO.BENCO or benco.com

When Using This Product

Avoid contact with eyes. If contact occurs, flush with water.

Do Not Exceed Recommended

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.


Structured Label Content

Indications and Usage (34067-9)

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

Section 51945-4 (51945-4)

Purpose

Oral Anesthetic

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

Directions

• Apply only amount needed to

the oral mucosa to prevent or

relieve pain.

• children under 2 years of age:

do not use

Do Not Use (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

Allergy Alert

Allergy Alert Do not use on

patients with a history of

allergies to local anesthetics

suchasprocaine,butacaine,

benzocaine or other "caine"

anesthetics.

Other Information

Store at 59 -86°F(15-30°C).

Protect from freezing.

Active Ingredients

Benzocaine 200 mg (in each g)

Inactive Ingredients

flavoring, PEG 3350, PEG 400, sodium saccharin.

Questions Or Comments? (Questions or Comments?)

800.GO.BENCO or benco.com

When Using This Product (When using this product)

Avoid contact with eyes. If contact occurs, flush with water.

Do Not Exceed Recommended (Do not exceed recommended)

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, (If pregnant or breast feeding,)

ask a physician before use.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)