Xesso Neo 5% Benzocaine Oral Spray

Xesso Neo 5% Benzocaine Oral Spray
SPL v5
SPL
SPL Set ID 163f32cd-4e51-950a-e063-6394a90a4816
Routes
ORAL TOPICAL
Published
Effective Date 2025-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (5 g)
Inactive Ingredients
Povidone, Unspecified Polyoxyl 40 Castor Oil Sucralose Fd&c Red No. 40 Glycerin Water Alcohol 95%

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-16

Description

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 the blood. 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. 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. For adult use only. Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other ‘caine’ anesthetics. Keep this and all drugs out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center right away. As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product. Stop use and consult a doctor if difficulty in breathing occurs, swelling or fever develops, or if sore mouth or throat symptoms do not improve within 7 days. Do not exceed the recommended dosage. Keep away from fire or flames.

Purpose

Oral Anesthetic


Medication Information

Purpose

Oral Anesthetic

Description

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 the blood. 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. 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. For adult use only. Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other ‘caine’ anesthetics. Keep this and all drugs out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center right away. As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product. Stop use and consult a doctor if difficulty in breathing occurs, swelling or fever develops, or if sore mouth or throat symptoms do not improve within 7 days. Do not exceed the recommended dosage. Keep away from fire or flames.

Warning
  • 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 the blood. 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.
  • 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. For adult use only.
  • Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other ‘caine’ anesthetics.
  • Keep this and all drugs out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center right away.
  • As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.
  • Stop use and consult a doctor if difficulty in breathing occurs, swelling or fever develops, or if sore mouth or throat symptoms do not improve within 7 days.
  • Do not exceed the recommended dosage.
  • Keep away from fire or flames.
Directions

Apply to the affected area (one spray).

Allow to remain in place for at least 15 seconds then spit out.

May be repeated every two hours as needed or as directed by a health care professional.

Use Section

For temporary relief of minor throat irritation, pain, and sore throat.

Active Ingredient

Benzocaine 5%

Other Information

Tamper-Evident: Do not use if tamper evident seal on the outside of the container is broken or missing.

Store at room temperature 20 - 25 C (68 - 77 F)

Pdp and Back Panel

Inactive Ingredients

Alcohol, FD&C RED NO. 40, Glycerin, Natural Flavors, PEG-40 Hydrogenated Castor Oil, Polyvinylpyrrolidone (PVP), Sucralose, Water.

Keep Out of Reach of Children Section

Keep this and all drugs out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center right away.


Structured Label Content

Purpose

Oral Anesthetic

Warning
  • 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 the blood. 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.
  • 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. For adult use only.
  • Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other ‘caine’ anesthetics.
  • Keep this and all drugs out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center right away.
  • As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.
  • Stop use and consult a doctor if difficulty in breathing occurs, swelling or fever develops, or if sore mouth or throat symptoms do not improve within 7 days.
  • Do not exceed the recommended dosage.
  • Keep away from fire or flames.
Directions

Apply to the affected area (one spray).

Allow to remain in place for at least 15 seconds then spit out.

May be repeated every two hours as needed or as directed by a health care professional.

Use Section

For temporary relief of minor throat irritation, pain, and sore throat.

Active Ingredient

Benzocaine 5%

Other Information

Tamper-Evident: Do not use if tamper evident seal on the outside of the container is broken or missing.

Store at room temperature 20 - 25 C (68 - 77 F)

Pdp and Back Panel (PDP and Back Panel)

Inactive Ingredients

Alcohol, FD&C RED NO. 40, Glycerin, Natural Flavors, PEG-40 Hydrogenated Castor Oil, Polyvinylpyrrolidone (PVP), Sucralose, Water.

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

Keep this and all drugs out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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