5820303 Cvs Mouth Sore Relief

5820303 Cvs Mouth Sore Relief
SPL v24
SPL
SPL Set ID 1b7209f6-8368-47fa-8df2-b049613b8c1b
Route
ORAL
Published
Effective Date 2025-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Alcohol Ethylcelluloses Tannic Acid Cetylpyridinium Chloride Sucralose Benzyl Alcohol Propylene Glycol Oleth-10 Dimethyl Isosorbide Ricinus Communis Seed Polyethylene Glycol 300 Benzoin, (+/-)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-10-01

Description

Benzocaine 20%

Purpose

Oral Anesthetic/Analgesic


Medication Information

Warnings and Precautions

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 oocur even if you have use this product before. stop ise and seek immediate medical attention if you or a child in you care develops:

  • palre, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shotness of breath
  • dizziness or lightheadedness
  • fatique 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

When using this product

  • do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; f swelling, rash, of fever develops, see your dentist or doctor promptly.







Purpose

Oral Anesthetic/Analgesic

Description

Benzocaine 20%

Uses

for the temporary relief of pain due to canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums

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.

Section 51945-4

Directions
  • to assure formation of long-lasting film coating, dry affected area and apply medication undiluted with applicator
  • allow a few seconds for coating to form
  • 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: consult a dentist or doctor

Active Ingredient

Benzocaine 20%

Other Information

• do not purchase if package has been opened



• cap tightly after use to avoid evaporation



• avoid contact with eyes



• avoid contact with clothing and household/furniture surfaces to prevent possible staining



• this is a personal care item, and should be used by one individual only

Inactive Ingredients

Benzyl Alcohol, Cetylpyridinium Chloride, Compound Benzoin Tincture, Dimethyl Isosorbide, Ethylcellulose, Flavor, Octylacrylamide/acrylates/butylaminoethyl/methacrylate Copolymer, Oleth-10, polyethylene glycol, Propylene Glycol, Ricinus Communis (Castor) seed Oil, SD Alcohol 38B, Sucralose,Tannic Acid


Structured Label Content

Uses

for the temporary relief of pain due to canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums

Warnings and Precautions (34071-1)

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 oocur even if you have use this product before. stop ise and seek immediate medical attention if you or a child in you care develops:

  • palre, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shotness of breath
  • dizziness or lightheadedness
  • fatique 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

When using this product

  • do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; f swelling, rash, of fever develops, see your dentist or doctor promptly.







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.

Section 51945-4 (51945-4)

Purpose

Oral Anesthetic/Analgesic

Directions
  • to assure formation of long-lasting film coating, dry affected area and apply medication undiluted with applicator
  • allow a few seconds for coating to form
  • 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: consult a dentist or doctor

Active Ingredient (Active ingredient)

Benzocaine 20%

Other Information

• do not purchase if package has been opened



• cap tightly after use to avoid evaporation



• avoid contact with eyes



• avoid contact with clothing and household/furniture surfaces to prevent possible staining



• this is a personal care item, and should be used by one individual only

Inactive Ingredients (Inactive ingredients)

Benzyl Alcohol, Cetylpyridinium Chloride, Compound Benzoin Tincture, Dimethyl Isosorbide, Ethylcellulose, Flavor, Octylacrylamide/acrylates/butylaminoethyl/methacrylate Copolymer, Oleth-10, polyethylene glycol, Propylene Glycol, Ricinus Communis (Castor) seed Oil, SD Alcohol 38B, Sucralose,Tannic Acid


Advanced Ingredient Data


Raw Label Data

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