FINAFTA MULTIORAL- benzocaine spray

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 7.5% ................ Oral Anesthetic/Analgesic

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.

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.

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.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FINAFTA  MULTIORAL
benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58593-782
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	7.5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58593-782-02	1 in 1 CARTON	09/01/2004
1		59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	09/01/2004

Labeler - Efficient Laboratories Inc. (969044932)