Finafta

Finafta
SPL v7
SPL
SPL Set ID 03368603-3e11-c2fa-e063-6294a90a04ea
Route
TOPICAL
Published
Effective Date 2023-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (5 mg) Glycerin (33 mg)
Inactive Ingredients
Propylparaben Polyethylene Glycol 1000 Phosphoric Acid Menthol Sucralose Methylparaben Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-15

Description

Active Ingredients: (%) Purpose Benzocaine USP 5%..................Oral Anesthetic Glycerin 33% .........................Oral Demulcen


Medication Information

Warnings and Precautions

Warnings

Do not exceed recommended dosage

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 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 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 this product 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; or if swelling, rash or fever develops, see your dentist or doctor promptly.

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 between 2 and 12 years of age: consult a doctor •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 Benzocaine USP 5%..................Oral Anesthetic Glycerin 33% .........................Oral Demulcen

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:



menthol, methylparaben, polyethylene glycol, propylparaben, propylene glycol, purified water, phosphoric acid, sucralose.

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

Oral Anesthetic

Oral Demulcen

Section 55106-9

Active Ingredients: (%) Purpose

Benzocaine USP 5%..................Oral Anesthetic

Glycerin 33% .........................Oral Demulcen

Other Information



• finafta is tolerable to iodine-sensitive individuals.

• store between 15° - 30°C (59° - 86°F).

• close bottle tightly after each use.

• Keep box for information.

Tamper-Evident:do not accept if safety seal is broken or missing.


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 between 2 and 12 years of age: consult a doctor •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

Do not exceed recommended dosage

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 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 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 this product 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; or if swelling, rash or fever develops, see your dentist or doctor promptly.

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:



menthol, methylparaben, polyethylene glycol, propylparaben, propylene glycol, purified water, phosphoric acid, sucralose.

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

Oral Anesthetic

Oral Demulcen

Section 55106-9 (55106-9)

Active Ingredients: (%) Purpose

Benzocaine USP 5%..................Oral Anesthetic

Glycerin 33% .........................Oral Demulcen

Other Information



• finafta is tolerable to iodine-sensitive individuals.

• store between 15° - 30°C (59° - 86°F).

• close bottle tightly after each use.

• Keep box for information.

Tamper-Evident:do not accept if safety seal is broken or missing.


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Raw Label Data

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