Finafta Baby

Dosage form: liquid
Ingredients: BENZOCAINE 7.5mg in 100mg
Labeler: Efficient Laboratories Inc.
NDC Code: 58593-781

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.

Drug Facts

Active Ingredients: (%)              Purpose

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

Purpose

Analgesic

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  BABY
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
1NDC:58593-781-027100 mg in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/01/2000
Labeler - Efficient Laboratories Inc. (969044932)

Revised: 02/2014
 
Efficient Laboratories Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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