Finafta Multioral

Finafta Multioral
SPL v1
SPL
SPL Set ID cb027ab8-4175-4cc0-a73e-991dfb113df9
Route
ORAL
Published
Effective Date 2025-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (7.5 mg)
Inactive Ingredients
Benzalkonium Chloride Methylparaben Peppermint Oil Phosphoric Acid Propylene Glycol Propylparaben Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-09-01

Description

Active Ingredients: (%)              Purpose Benzocaine USP 7.5% ................ Oral Anesthetic/Analgesic


Medication Information

Warnings and Precautions

Warnings: Do not exceed recommended dosage

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.



Do not use

  • for teething
  • in children under 2 years of age

Consult a doctor promptly if:

sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens. If sore throat is sever, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting.

Indications and Usage

USES

For the temporary relief of occasional minor irritation, pain, sore mouth, pain associated with canker sores or pain due to minor irritation of the mouth and gums cause by dentures or othodontic applicances.

Dosage and Administration

DIRECTIONS:

For children over 12 years of age and Adults

• Apply Finafta® MultiOral Spray up to 4 times daily to affected areas of the mouth, gums or mucus membranes (mouth and throat).

  • Allow to remain in place at least 1 minute and then spit out.

• Close bottle tightly after each use.

  • Children under 12 years of age: Do not use.
Description

Active Ingredients: (%)              Purpose Benzocaine USP 7.5% ................ Oral 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:



Benzalkonium chloride, glycerin, methylparaben, peppermint oil, phosphoric acid, propylene glycol, propylparaben 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 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

Purpose

Oral Anesthetic/Analgesic

Section 55106-9

Active Ingredients: (%)              Purpose

Benzocaine USP 7.5% ................ Oral Anesthetic/Analgesic




Structured Label Content

Indications and Usage (34067-9)

USES

For the temporary relief of occasional minor irritation, pain, sore mouth, pain associated with canker sores or pain due to minor irritation of the mouth and gums cause by dentures or othodontic applicances.

Dosage and Administration (34068-7)

DIRECTIONS:

For children over 12 years of age and Adults

• Apply Finafta® MultiOral Spray up to 4 times daily to affected areas of the mouth, gums or mucus membranes (mouth and throat).

  • Allow to remain in place at least 1 minute and then spit out.

• Close bottle tightly after each use.

  • Children under 12 years of age: Do not use.
Warnings and Precautions (34071-1)

Warnings: Do not exceed recommended dosage

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.



Do not use

  • for teething
  • in children under 2 years of age

Consult a doctor promptly if:

sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens. If sore throat is sever, persists for more than 2 days, 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:



Benzalkonium chloride, glycerin, methylparaben, peppermint oil, phosphoric acid, propylene glycol, propylparaben 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 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Oral Anesthetic/Analgesic

Section 55106-9 (55106-9)

Active Ingredients: (%)              Purpose

Benzocaine USP 7.5% ................ Oral Anesthetic/Analgesic




Advanced Ingredient Data


Raw Label Data

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