5820636 Cvs Oral Anesthetic Gel (8015316)

5820636 Cvs Oral Anesthetic Gel (8015316)
SPL v9
SPL
SPL Set ID 92747826-cf58-4406-b3b5-12f7c7077c2c
Route
ORAL
Published
Effective Date 2024-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g)
Inactive Ingredients
Polyethylene Glycol 400 Propylene Glycol Saccharin Sodium Sorbic Acid Glycerin Fd&c Red No. 40 D&c Yellow No. 10 Fd&c Blue No. 1 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2011-01-20 Until 2024-10-31

Description

Benzocaine 20%

Purpose

Oral pain reliever


Medication Information

Warnings and Precautions

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.

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.

Purpose

Oral pain reliever

Description

Benzocaine 20%

Use

temporarily relieves pain associated with mouth and gum irritations, toothache, sore gums, canker sores, braces, minor dental procedures, dentures

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 (1-800-222-1222).

Section 50570-1

Do not use for teething, in children under 2 years of age

Section 51945-4

Directions
  • to open tube, cut tip of 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 dentist/doctor.
  • 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 a thin layer to the affected area; do not reinsert dental work intil irritation/pain is relieved; rinse mouth well after reinserting
Active Ingredient

Benzocaine 20%

Inactive Ingredients

Blue 1, Carbomer, Flavor, Glycerin, Polyethylene Glycol, Propylene Glycol, Red 40, Sodium Saccharin, Sorbic Acid, Water, Yellow 10


Structured Label Content

Use

temporarily relieves pain associated with mouth and gum irritations, toothache, sore gums, canker sores, braces, minor dental procedures, dentures

Warnings and Precautions (34071-1)

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.

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.

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 (1-800-222-1222).

Section 50570-1 (50570-1)

Do not use for teething, in children under 2 years of age

Section 51945-4 (51945-4)

Purpose

Oral pain reliever

Directions
  • to open tube, cut tip of 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 dentist/doctor.
  • 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 a thin layer to the affected area; do not reinsert dental work intil irritation/pain is relieved; rinse mouth well after reinserting
Active Ingredient (Active ingredient)

Benzocaine 20%

Inactive Ingredients (Inactive ingredients)

Blue 1, Carbomer, Flavor, Glycerin, Polyethylene Glycol, Propylene Glycol, Red 40, Sodium Saccharin, Sorbic Acid, Water, Yellow 10


Advanced Ingredient Data


Raw Label Data

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