FINAFTA  MULTIORAL- benzocaine spray 
Efficient Laboratories Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients: (%)              Purpose

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

Purpose

Oral Anesthetic/Analgesic

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:

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

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.

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

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

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).

• Close bottle tightly after each use.

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 ingredients:


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

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

FinaftaMulti

FINAFTA   MULTIORAL
benzocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-782
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE7.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58593-782-021 in 1 CARTON09/01/2004
159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/01/2004
Labeler - Efficient Laboratories Inc. (969044932)
Establishment
NameAddressID/FEIBusiness Operations
Dextrum Laboratories Inc.007392322manufacture(58593-782)

Revised: 12/2021
Document Id: d230102e-3eb7-4ace-e053-2a95a90a5b3c
Set id: 28c5a993-fb5f-4091-af15-32ccae4b9a7d
Version: 10
Effective Time: 20211202
 
Efficient Laboratories Inc.