FINAFTA BABY- benzocaine liquid 
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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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

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


Do not use for more than 7 days unless directed 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 do not go away, advise your dentist or doctor.

Stop use of this product if sore mouth symptoms do not get better 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 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, 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 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

FinaftaBabyLabel

FINAFTA  BABY
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:58593-781
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE7.5 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER 934 
METHYLPARABEN 
POLYOXYL 8 STEARATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58593-781-027100 mg in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35601/01/2000
Labeler - Efficient Laboratories Inc. (969044932)

Revised: 5/2011
 
Efficient Laboratories Inc.