FINAFTA- benzocaine, glycerin liquid 
Efficient Laboratories Inc.

----------

Finafta

Active Ingredients: (%) Purpose

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

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

Purpose

Oral Anesthetic

Oral Demulcen

Uses

For temporary relief of pain associated with canker sores

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:

Allergy alert

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. In case of accidental overdose: Get medical help or contact a Poison Control Center right away.

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 or comments?

305-805-3456

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

www.efficientlabs.com

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.

label

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)

Revised: 12/2023
Document Id: 5e9fcd9a-779f-423e-909a-29eb285b8302
Set id: 03368603-3e11-c2fa-e063-6294a90a04ea
Version: 2
Effective Time: 20231227
 
Efficient Laboratories Inc.