Benzocaine 20% Pain Relieving Gel

Benzocaine 20% Pain Relieving Gel
SPL v3
SPL
SPL Set ID 105d87d6-9147-43d4-e063-6394a90a57ee
Route
TOPICAL
Published
Effective Date 2024-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (0.2 g)
Inactive Ingredients
Glycerin Polysorbate 80 Propylene Glycol Saccharin Sodium D&c Red No. 33 Fd&c Yellow No. 6 Benzyl Alcohol Fd&c Blue No. 1 Carbomer Homopolymer, Unspecified Type Polyethylene Glycol, Unspecified Sorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-01

Description

Benzocaine 20%

Purpose

Oral pain reliever


Medication Information

Purpose

Oral pain reliever

Description

Benzocaine 20%

Uses

temporarily relieves pain associated with the following mouth and gum irritations:

  • toothache
  • canker sores
  • minor dental procedures
  • dentures
  • sore gums
  • braces
Section 51945-4

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:

  • for teething
  • in children under 2 years of age
Directions
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
Other Information
  • store at 20-25°C (68-77°F)
  • do not refrigerate
Active Ingredients

Benzocaine 20%

Inactive Ingredients

benzyl alcohol, carbomer, D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, sodium saccharin, sorbic acid

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
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
Keep Out of Reach of Children

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.


Structured Label Content

Uses

temporarily relieves pain associated with the following mouth and gum irritations:

  • toothache
  • canker sores
  • minor dental procedures
  • dentures
  • sore gums
  • braces
Section 51945-4 (51945-4)

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:

  • for teething
  • in children under 2 years of age
Directions
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
Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • do not refrigerate
Active Ingredients (Active ingredients)

Benzocaine 20%

Inactive Ingredients (Inactive ingredients)

benzyl alcohol, carbomer, D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, sodium saccharin, sorbic acid

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
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
Keep Out of Reach of Children (Keep out of reach of children)

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.


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