benzocaine 20% spray

benzocaine 20% spray
SPL v1
SPL
SPL Set ID 2bc57111-0f15-b237-e063-6294a90a4471
Routes
periodontal dental
Published
Effective Date 2025-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzocaine (200 mg)
Inactive Ingredients
polyethylene glycol 400 sucralose cherry

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-01-15

Purpose

Oral Anesthetic

Description

Benzocaine 20%


Medication Information

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

​Sore throat warning:if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.

Indications and Usage

Usesfor the temporary relief of occasional minor irritation and pain associated with sore mouth and throat

Purpose

Oral Anesthetic

Directions
  • do not exceed recommended dosage

adults and children 2 years of age and older: 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 the product

children under 2 years of age: do not use

Other Information
  • store at 15-30 °C (59-86 °F)
Inactive Ingredients

cherry flavor, polyethylene glycol, sucralose

Description

Benzocaine 20%

Principal Display Panel

EverPharm

NDC 84415-044-01

Benzocaine 20% Spray

Unit Dose Non-Aerosol Spray

20% Benzocaine Oral Anesthetic

25 Unit Dose Non-Aerosol Sprays

0.017 fl.oz. (0.5 mL)

Do Not Use
  • if foil pouch has been previously opened
  • for teething
  • in children under 2 years of age
Drug Facts

Active Ingredient

Benzocaine 20%

Questions Or Comments?

(855) 879-4368

When Using This Product
  • avoid contact with eyes
Keep Out of Reach of Children.

If more than used for pain is accidently swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) Immediately


Structured Label Content

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

​Sore throat warning:if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.

Indications and Usage (34067-9)

Usesfor the temporary relief of occasional minor irritation and pain associated with sore mouth and throat

Purpose

Oral Anesthetic

Directions
  • do not exceed recommended dosage

adults and children 2 years of age and older: 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 the product

children under 2 years of age: do not use

Other Information (Other information)
  • store at 15-30 °C (59-86 °F)
Inactive Ingredients (Inactive ingredients)

cherry flavor, polyethylene glycol, sucralose

Principal Display Panel

EverPharm

NDC 84415-044-01

Benzocaine 20% Spray

Unit Dose Non-Aerosol Spray

20% Benzocaine Oral Anesthetic

25 Unit Dose Non-Aerosol Sprays

0.017 fl.oz. (0.5 mL)

Do Not Use (Do not use)
  • if foil pouch has been previously opened
  • for teething
  • in children under 2 years of age
Drug Facts

Active Ingredient

Benzocaine 20%

Questions Or Comments? (Questions or comments?)

(855) 879-4368

When Using This Product (When using this product)
  • avoid contact with eyes
Keep Out of Reach of Children. (Keep out of reach of children.)

If more than used for pain is accidently swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) Immediately


Advanced Ingredient Data


Raw Label Data

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