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Finafta

Efficient Laboratories Inc.

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients: (%)              Purpose

Benzocaine USP 7.5% w/w................ Analgesic

Purpose

Purpose

Analgesic

Uses

USES

For the temporary relief of sore gums due to teething in infants and children 4 months of age and older.

Warnings

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 your doctor.

Do not use for more than 7 days unless directed by a dentist or doctor

Allergy Alert: Do not use this product if your baby has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caines" anesthetics.

Stop use of this product and consult your doctor or dentist if sore mouth symptoms do not get better in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash or fever develops.


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.

Directions
Wash hands. Cut open tip on score mark with scissors Use your fingertips or cotton applicator to apply a small pea size amount of formula. Apply to affected area not more than four times daily or as directed by a dentist or doctor For infants under 4 months of age, there is no recommended dosage or treatment, except under the advice of a doctor/dentist

Inactive ingredients Carbomer, flavor, Methylparaben and PEG-8

Questions or Comments?

1-305-805-3456

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

www.efficientlabs.com


Distributed by
Efficient Laboratories, Inc. Miami Fl 33166 USA

Finafta

Finafta

Benzocaine LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58593-781
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 7.5 mg

Inactive Ingredients

Ingredient Name Strength
CARBOMER 934
METHYLPARABEN
POLYOXYL 8 STEARATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58593-781-02 7100 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2000-01-01


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Be sure to consult your doctor before taking any medication!
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