Anbesol ®

Anbesol ®
SPL v4
SPL
SPL Set ID dcc37403-0192-4658-bb7a-059273ce0047
Route
TOPICAL
Published
Effective Date 2021-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Benzyl Alcohol Carbomer Homopolymer Type B (allyl Pentaerythritol Or Allyl Sucrose Crosslinked) D&c Yellow No. 10 Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Methylparaben Polyethylene Glycol, Unspecified Polysorbate 80 Propylene Glycol Saccharin

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-15

Description

Drug Facts

Purpose

Oral pain reliever


Medication Information

Purpose

Oral pain reliever

Description

Drug Facts

Uses
  • temporarily relieves pain associated with the following mouth and gum irritations:
    • toothache
    • sore gums
    • canker sores
    • braces
    • minor dental procedures
    • dentures
Section 42229-5

Drug Facts

Section 50565-1

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
  • to open tube, cut tip of the tube on score mark with scissors
    adults and children 2 years of age and over apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist
    children under 12 years of age adult supervision should be given in the use of this product
    children under 2 years of age do not use
  • for denture irritation:
    • apply thin layer to the affected area
    • do not reinsert dental work until irritation/pain is relieved
    • rinse mouth well before reinserting
Do Not Use
  • for teething
  • in children under 2 years of age
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.

Active Ingredient

Benzocaine 20%

Other Information
  • store at 20-25°C (68-77°F)
  • do not refrigerate
Inactive Ingredients

benzyl alcohol, carbomer 934P, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, glycerin, methylparaben, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, saccharin

Questions Or Comments?

Call 1-888-594-0673weekdays 9 AM to 5 PM EST

When Using This Product
  • avoid contact with the eyes
  • do not exceed recommended dosage
  • do not use for more than 7 days unless directed by a doctor/dentist
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. 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
Stop Use and Ask A Doctor If
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness lasts or worsens
  • swelling, rash, or fever develops
Principal Display Panel 9 G Tube Blister Pack

MAXIMUM STRENGTH

20% Benzocaine

Anbesol ®

Oral Pain Reliever/Benzocaine 20%

Instant Oral

Pain Relief

ADA Accepted

American Dental Association

  • Toothaches
  • Canker Sores
  • Aligner Pain
  • Gum Pain

GEL

NET WT 0.33 OZ (9 g)


Structured Label Content

Uses
  • temporarily relieves pain associated with the following mouth and gum irritations:
    • toothache
    • sore gums
    • canker sores
    • braces
    • minor dental procedures
    • dentures
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Purpose

Oral pain reliever

Directions
  • to open tube, cut tip of the tube on score mark with scissors
    adults and children 2 years of age and over apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist
    children under 12 years of age adult supervision should be given in the use of this product
    children under 2 years of age do not use
  • for denture irritation:
    • apply thin layer to the affected area
    • do not reinsert dental work until irritation/pain is relieved
    • rinse mouth well before reinserting
Do Not Use (Do not use)
  • for teething
  • in children under 2 years of age
Allergy Alert (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.

Active Ingredient (Active ingredient)

Benzocaine 20%

Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • do not refrigerate
Inactive Ingredients (Inactive ingredients)

benzyl alcohol, carbomer 934P, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, glycerin, methylparaben, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, saccharin

Questions Or Comments? (Questions or comments?)

Call 1-888-594-0673weekdays 9 AM to 5 PM EST

When Using This Product (When using this product)
  • avoid contact with the eyes
  • do not exceed recommended dosage
  • do not use for more than 7 days unless directed by a doctor/dentist
Methemoglobinemia Warning (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. 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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness lasts or worsens
  • swelling, rash, or fever develops
Principal Display Panel 9 G Tube Blister Pack (PRINCIPAL DISPLAY PANEL - 9 g Tube Blister Pack)

MAXIMUM STRENGTH

20% Benzocaine

Anbesol ®

Oral Pain Reliever/Benzocaine 20%

Instant Oral

Pain Relief

ADA Accepted

American Dental Association

  • Toothaches
  • Canker Sores
  • Aligner Pain
  • Gum Pain

GEL

NET WT 0.33 OZ (9 g)


Advanced Ingredient Data


Raw Label Data

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