FINAFTA BABY - benzocaine liquid 
Efficient Laboratories Inc.

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Drug Facts

Active Ingredients: (%)              Purpose

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

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

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

• if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caines" anesthetics
• Fever and nasal congestion are not symptoms of teether and may indicate the presence of infection, if these symptoms persist consult your doctor
  

Stop use of this product

• If sore moth 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. Do not exceed recommended dosage
  

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. If pregnant or breast-feeding consult a health professional before use.
  

Keep out of reach of children.

If pregnant or breast-feeding, ask a health professional before use.

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, these is no recommended dosage or treatment, except under the advice of a doctor/dentist
  

Other information

• Safety sealed tube: do not use if tube tip is cut prior to opening
• For adult pain relief of mouth and gums try Finafta for adults
• Store between 15-30 degrees C (59-86 degrees F)
• Keep the box for instructions
  

Inactive ingredients Carbomer 934P, 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  BABY benzocaine   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 58593-781 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (BENZOCAINE) BENZOCAINE 7.5 mg  in 100 mg

Inactive Ingredients Ingredient Name Strength CARBOMER 934   METHYLPARABEN   POLYOXYL 8 STEARATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 58593-781-02 7100 mg In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part356	01/01/2000

Labeler - Efficient Laboratories Inc. (969044932)

Revised: 03/2011Efficient Laboratories Inc.