Finafta

Finafta
SPL v10
SPL
SPL Set ID 1410fa91-d1bc-4797-b888-9b6971f643e0
Route
TOPICAL
Published
Effective Date 2020-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (60 mL) Salicylic Acid (1 mg) Benzocaine (5 mg)
Inactive Ingredients
Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 1991-10-01 Until 2026-06-01

Description

Active Ingredients: (%)              Purpose Ethyl Alcohol 60% v/v........................Anesthetic/Analgesic Salicylic Acid 1% w/v.........................Anesthetic/Analgesic Benzocaine USP 5% w/v...................Anesthetic/Analgesic


Medication Information

Warnings and Precautions

Warnings

Methemoglobinemia warning: Use of this product may cause mthemoglobinemia, a serious condition that must be treated promptyly because it reduces the amount of oxygen carried in the 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 enegry

Allegry alert

  • do not use this product if you have a history of allergy to local anesthetics such as prcaine, butacaine, bezocaine, or other "caine" anesthetics.

Alcogol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whehter you should take slicylic acid or other pain reliever, fever reducer. Salicylic acid may cause stomach bleeding.

Flammable: Keep away from fire or flame.

Do not use

  • for teething
  • in children under 2 years of age

When using this prduct Do not use near eyes. Do not prolong usage unless directed by a doctor/dentist.

Stop use and ask a doctor promptly if sore mouth symptoms do not improve in 7 days or if irritation, pain or redness persists or worsens. If you sore throat is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting.

Indications and Usage

Uses

For temporary relief of pain associated with canker sores

Dosage and Administration

Directions

Adults and children over 12 years of age apply to the affected area, mouth, gums or mucous membrane with the applicator provided, up to 4 times daily or as directed by a dentist or doctor. Remain in place at least 1 minute and then spit out. Do not rinse mouth after each use. Children under 12 years of age should be supervised in the use of the product. Do not use in children under 2 years of age. 

Description

Active Ingredients: (%)              Purpose Ethyl Alcohol 60% v/v........................Anesthetic/Analgesic Salicylic Acid 1% w/v.........................Anesthetic/Analgesic Benzocaine USP 5% w/v...................Anesthetic/Analgesic

Section 50565-1

Keep out of reach of children. In case of accidental overdose: Get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive Ingredients:

Propylene Glycol and Purified Water.

Section 51945-4

Section 53413-1

Questions or comments?

305-805-3456

Monday-Friday (9 a.m. - 5 p.m. EST)

www.efficientlabs.com

Section 55105-1

Purpose

Anesthetic/Analgesic

Section 55106-9

Active Ingredients: (%)              Purpose

Ethyl Alcohol 60% v/v........................Anesthetic/Analgesic

Salicylic Acid 1% w/v.........................Anesthetic/Analgesic

Benzocaine USP 5% w/v...................Anesthetic/Analgesic


Structured Label Content

Indications and Usage (34067-9)

Uses

For temporary relief of pain associated with canker sores

Dosage and Administration (34068-7)

Directions

Adults and children over 12 years of age apply to the affected area, mouth, gums or mucous membrane with the applicator provided, up to 4 times daily or as directed by a dentist or doctor. Remain in place at least 1 minute and then spit out. Do not rinse mouth after each use. Children under 12 years of age should be supervised in the use of the product. Do not use in children under 2 years of age. 

Warnings and Precautions (34071-1)

Warnings

Methemoglobinemia warning: Use of this product may cause mthemoglobinemia, a serious condition that must be treated promptyly because it reduces the amount of oxygen carried in the 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 enegry

Allegry alert

  • do not use this product if you have a history of allergy to local anesthetics such as prcaine, butacaine, bezocaine, or other "caine" anesthetics.

Alcogol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whehter you should take slicylic acid or other pain reliever, fever reducer. Salicylic acid may cause stomach bleeding.

Flammable: Keep away from fire or flame.

Do not use

  • for teething
  • in children under 2 years of age

When using this prduct Do not use near eyes. Do not prolong usage unless directed by a doctor/dentist.

Stop use and ask a doctor promptly if sore mouth symptoms do not improve in 7 days or if irritation, pain or redness persists or worsens. If you sore throat is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose: Get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredients:

Propylene Glycol and Purified Water.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

305-805-3456

Monday-Friday (9 a.m. - 5 p.m. EST)

www.efficientlabs.com

Section 55105-1 (55105-1)

Purpose

Anesthetic/Analgesic

Section 55106-9 (55106-9)

Active Ingredients: (%)              Purpose

Ethyl Alcohol 60% v/v........................Anesthetic/Analgesic

Salicylic Acid 1% w/v.........................Anesthetic/Analgesic

Benzocaine USP 5% w/v...................Anesthetic/Analgesic


Advanced Ingredient Data


Raw Label Data

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