FDA Label for Finafta
View Indications, Usage & Precautions
Finafta Product Label
The following document was submitted to the FDA by the labeler of this product Efficient Laboratories Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredients: (%) Purpose
Ethyl Alcohol 60% v/v........................Anesthetic/Analgesic
Salicylic Acid 1% w/v.........................Anesthetic/Analgesic
Benzocaine USP 5% w/v...................Anesthetic/Analgesic
Otc - Purpose
Purpose
Anesthetic/Analgesic
Indications & Usage
Uses
For temporary relief of pain associated with canker sores
Warnings
Warnings
Methemoglobinemia warning: Use of this product may cause mthemoglobinemia, a serious condition that must be treated promptyly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of enegry
- do not use this product if you have a history of allergy to local anesthetics such as prcaine, butacaine, bezocaine, or other "caine" anesthetics.
- for teething
- in children under 2 years of age
Allegry alert
Alcogol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whehter you should take slicylic acid or other pain reliever, fever reducer. Salicylic acid may cause stomach bleeding.
Flammable: Keep away from fire or flame.
Do not use
When using this prduct Do not use near eyes. Do not prolong usage unless directed by a doctor/dentist.
Stop use and ask a doctor promptly if sore mouth symptoms do not improve in 7 days or if irritation, pain or redness persists or worsens. If you sore throat is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose: Get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
Adults and children over 12 years of age apply to the affected area, mouth, gums or mucous membrane with the applicator provided, up to 4 times daily or as directed by a dentist or doctor. Remain in place at least 1 minute and then spit out. Do not rinse mouth after each use. Children under 12 years of age should be supervised in the use of the product. Do not use in children under 2 years of age.
Otc - Questions
Questions or comments?
305-805-3456
Monday-Friday (9 a.m. - 5 p.m. EST)
www.efficientlabs.com
Inactive Ingredient
Inactive Ingredients:
Propylene Glycol and Purified Water.
Package Label.Principal Display Panel
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