FINAFTA BABY- benzocaine 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 7.5% w/w................ Analgesic

PURPOSE

Purpose

Oral Pain reliever

INDICATIONS & USAGE

USES

For the temporary relief of sore gums due to teething in children 2 years or older

WARNINGS

Warnings

METHEMOGLOBINEMIA WARNING Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Stop use and seek immediate medical attention if you or a child in your care develops:

• pale, gray or blue colored skin (cyanosis)
• headached
• 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 procain, butacaine, benzocaine or other "caine" anesthetics. Do not exceed recommended dosage

Do not use

• more than directed
• more than 7 daysunless told to do so by a dentist or doctor

When using this product fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult a doctor.

Stop use of this product and consult your doctor or dentist if

• sore mouth symptoms do not improve in 7 days
• irritation, pain or redness does not go away, swelling, rash or fever develops

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions
Wash hands. Cut open tip of tube. Use your fingertips or cotton applicator to apply a small pea size amount of Finafta Baby and spreadover the gums. Apply to affected area up to 4 times daily or as directed by a physician or healthcare provider. Children under 12 years of age: should be supervised in the use of this product. Children under 2 years of age: consult a dentist or doctor.

INACTIVE INGREDIENT

Inactive ingredients D&C Yellow No. 10, FD&C Red No. 40, Flavor, Glycerin, PEG-6, PEG-75, PEG-32, Sodium Saccharin, Sorbic Acid, Purified Water

QUESTIONS

Questions or Comments?

305-805-3456

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

www.efficientlabs.com

Distributed by
Efficient Laboratories, Inc. Miami Fl 33166 USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FINAFTA  BABY
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58593-781
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 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58593-781-02	7100 mg in 1 TUBE; Type 0: Not a Combination Product	01/01/2000

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/01/2000

Labeler - Efficient Laboratories Inc. (969044932)