Anbesol ®

Anbesol ®
SPL v4
SPL
SPL Set ID 8c6ac499-9bd2-4ea5-9f26-df7947bff4a6
Route
TOPICAL
Published
Effective Date 2023-08-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Benzyl Alcohol D&c Yellow No. 10 Fd&c Blue No. 1 Fd&c Red No. 40 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
adults and children 2 years of age and over wipe liquid on with cotton, or cotton swab, or fingertip, apply 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)

Inactive Ingredients

benzyl alcohol, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, 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 12 Ml Bottle 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

LIQUID

0.41 FL OZ (12 mL)


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
adults and children 2 years of age and over wipe liquid on with cotton, or cotton swab, or fingertip, apply 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)

Inactive Ingredients (Inactive ingredients)

benzyl alcohol, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, 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 12 Ml Bottle Blister Pack (PRINCIPAL DISPLAY PANEL - 12 mL Bottle 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

LIQUID

0.41 FL OZ (12 mL)


Advanced Ingredient Data


Raw Label Data

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