FDA Label for Finafta Multioral
View Indications, Usage & Precautions
Finafta Multioral 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
Benzocaine USP 7.5% ................ Oral Anesthetic/Analgesic
Otc - Purpose
Purpose
Oral Anesthetic/Analgesic
Warnings
Warnings: Do not exceed recommended dosage
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
- for teething
- in children under 2 years of age
Allegry alert
do not use this product if you have a history of allergy to local anesthetics such as prcaine, butacaine, bezocaine, or other "caine" anesthetics.
Do not use
Consult a doctor promptly if:
sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens. If sore throat is sever, persists for more than 2 days, 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Dosage & Administration
DIRECTIONS:
For children over 12 years of age and Adults
• Apply Finafta® MultiOral Spray up to 4 times daily to affected areas of the mouth, gums or mucus membranes (mouth and throat).
- Allow to remain in place at least 1 minute and then spit out.
- Children under 12 years of age: Do not use.
• Close bottle tightly after each use.
Indications & Usage
USES
For the temporary relief of occasional minor irritation, pain, sore mouth, pain associated with canker sores or pain due to minor irritation of the mouth and gums cause by dentures or othodontic applicances.
Inactive Ingredient
Inactive ingredients:
Benzalkonium chloride, glycerin, methylparaben, peppermint oil, phosphoric acid, propylene glycol, propylparaben and purified water.
Otc - Questions
QUESTIONS OR COMMENTS?
305-805-3456
Monday-Friday (9 a.m.- 5 p.m. EST)
www.efficientlabs.com
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