FINAFTA- benzocaine, glycerin liquid

Finafta by

Drug Labeling and Warnings

Finafta by is a Otc medication manufactured, distributed, or labeled by Efficient Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

FINAFTA 
benzocaine, glycerin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58593-783
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	5 mg  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	33 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58593-783-15	15 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	09/15/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	09/15/2023

Labeler - Efficient Laboratories Inc. (969044932)