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

Purpose

Oral Pain reliever

USES

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

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. 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 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 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 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

FinaftaBabyLabel

FINAFTA  BABY
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-781
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE7.5 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58593-781-027100 mg in 1 TUBE; Type 0: Not a Combination Product01/01/200007/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/01/200007/31/2020
Labeler - Efficient Laboratories Inc. (969044932)
Establishment
NameAddressID/FEIBusiness Operations
Efficient Laboratories Inc.969044932label(58593-781)

Revised: 9/2022
Document Id: e82feab0-a484-9844-e053-2a95a90a5d1d
Set id: 404d36c3-19a4-4fe9-803d-db9b910c0652
Version: 6
Effective Time: 20220908
 
Efficient Laboratories Inc.