Label: FINAFTA- benzocaine, glycerin liquid

  • NDC Code(s): 58593-783-15
  • Packager: Efficient Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 27, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients: (%) Purpose

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

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

  • PURPOSE

    Purpose

    Oral Anesthetic

    Oral Demulcen

  • INDICATIONS & USAGE

    Uses

    For temporary relief of pain associated with canker sores

  • WARNINGS

    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.

  • 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.

  • DOSAGE & 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.

  • QUESTIONS

    Questions or comments?

    305-805-3456

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

    www.efficientlabs.com

  • INACTIVE INGREDIENT

    Inactive Ingredients:


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

  • 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.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FINAFTA 
    benzocaine, glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-783
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN33 mg  in 100 mL
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    MENTHOL (UNII: L7T10EIP3A)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58593-783-1515 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02209/15/2023
    Labeler - Efficient Laboratories Inc. (969044932)