Anadent

Anadent
SPL v2
SPL
SPL Set ID e0f73d78-5db1-43b4-8f58-e5410ca4560f
Route
DENTAL
Published
Effective Date 2022-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Ammonium Glycyrrhizate Polyethylene Glycol 400 Polyethylene Glycol 3350 Saccharin Sodium Sorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-15

Description

Benzocaine 20%

Purpose

oral pain reliever


Medication Information

Purpose

oral pain reliever

Description

Benzocaine 20%

Uses
  • For the temporary relief of pain due to toothache
  • To help protect against infection of minor oral irritation.
Section 42229-5

20% BENZOCAINE TO RELIEVE ORAL PAIN 

COOLS GUM & RELIEVES IRRITATION

For toothaches

Toothache and Gum pain Relief Gel

TAMPER-EVIDENT:

Do not use if tube is cut prior to use.

Retain carton for complete product information.

Distributed by Belmora LLC, 3033 Wilson Blvd. Suite 700 Arlington, VA 22201 | www.anadentusa.com

Questions/Comments please call: 1 888 779 2877 Monday to Friday 9AM - 5PM EST

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 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 this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Do not use

  • more than directed   • for more than 7 days unless told to do so by a dentist or doctor
  • for teething    • in children under 2 years of age

Stop use and ask a dentist or doctor if 

  • swelling, rash or fever develops    • irritation, pain or redness persists or worsens
  • symptoms do not improve in 7 days   • allergic reaction occurs
Packaging

Directions
  • Cut open tip of tube on score mark
  • Adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor
  • Children under 12 years of age should be supervised in the use of this product
  • Children under 2 years of age: do not use 
Drug Facts

Active Ingredient

Benzocaine 20%

Other Information
  • Do not use if tip is cut prior to opening
  • This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
  • Do not use continuously
  • This formula will stay in place for extended duration of relief
  • Avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
Inactive Ingredients:

Ammonium Glycyrrhizate, Flavor, PEG-400, PEG-3350, Sodium Saccharin Dihydrate, Sorbic Acid


Structured Label Content

Uses
  • For the temporary relief of pain due to toothache
  • To help protect against infection of minor oral irritation.
Section 42229-5 (42229-5)

20% BENZOCAINE TO RELIEVE ORAL PAIN 

COOLS GUM & RELIEVES IRRITATION

For toothaches

Toothache and Gum pain Relief Gel

TAMPER-EVIDENT:

Do not use if tube is cut prior to use.

Retain carton for complete product information.

Distributed by Belmora LLC, 3033 Wilson Blvd. Suite 700 Arlington, VA 22201 | www.anadentusa.com

Questions/Comments please call: 1 888 779 2877 Monday to Friday 9AM - 5PM EST

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Purpose

oral pain reliever

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 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 this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Do not use

  • more than directed   • for more than 7 days unless told to do so by a dentist or doctor
  • for teething    • in children under 2 years of age

Stop use and ask a dentist or doctor if 

  • swelling, rash or fever develops    • irritation, pain or redness persists or worsens
  • symptoms do not improve in 7 days   • allergic reaction occurs
Packaging

Directions
  • Cut open tip of tube on score mark
  • Adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor
  • Children under 12 years of age should be supervised in the use of this product
  • Children under 2 years of age: do not use 
Drug Facts

Active Ingredient

Benzocaine 20%

Other Information
  • Do not use if tip is cut prior to opening
  • This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
  • Do not use continuously
  • This formula will stay in place for extended duration of relief
  • Avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
Inactive Ingredients:

Ammonium Glycyrrhizate, Flavor, PEG-400, PEG-3350, Sodium Saccharin Dihydrate, Sorbic Acid


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)