Finafta Spray
FDA Label NDC 58593-782

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Efficient Laboratories Inc. for the product Finafta (NDC 58593-782). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, indications & usage, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients: (%)              Purpose

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

Otc - Purpose

Purpose

Oral Anesthetic/Analgesic

Warnings

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.

Otc - Keep Out Of Reach Of Children

Keep Out of reach of children. In case of accidental overdose, get medical help or contact a Poison
Control Center right away.

Otc - Pregnancy Or Breast Feeding

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

Dosage & 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.

Indications & 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.

Inactive Ingredient

Inactive ingredients:


Benzalkonium chloride, glycerin, methylparaben, peppermint oil, phosphoric acid, propylene glycol, propylparaben and purified water.

Otc - Questions

QUESTIONS OR COMMENTS?
305-805-3456
Monday-Friday (9 a.m.- 5 p.m. EST)
www.efficientlabs.com

Package Label.Principal Display Panel

Finaftamulti (Finaftamultioral)

Finaftamulti (Finaftamultioral)

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