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.
Active Ingredients: (%) Purpose
Benzocaine USP 7.5% w/w................ Analgesic
Oral Pain reliever
For the temporary relief of sore gums due to teething in children 2 years or older
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)
- 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.
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?
Monday-Friday (9 a.m. - 5 p.m. EST)
Efficient Laboratories, Inc. Miami Fl 33166 USA
|Labeler - Efficient Laboratories Inc. (969044932)|
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.