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| Product NDC Code | 58593-782 | ||||
|---|---|---|---|---|---|
| Drug Name | Finafta multioral |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 1110816, 1110820 |
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| Application Number | M022 | ||||
| Labeler Name | Efficient Laboratories Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients: (%) Purpose Benzocaine USP 7.5% ................ Oral Anesthetic/Analgesic
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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. • Close bottle tightly after each use. Children under 12 years of age: Do not use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients : Benzalkonium chloride, glycerin, methylparaben, peppermint oil, phosphoric acid, propylene glycol, propylparaben and purified water.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Purpose
Information about the drug product’s indications for use.Purpose Oral Anesthetic/Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Finafta MultiOral Benzocaine BENZALKONIUM CHLORIDE METHYLPARABEN PEPPERMINT OIL PHOSPHORIC ACID PROPYLENE GLYCOL PROPYLPARABEN WATER GLYCERIN BENZOCAINE BENZOCAINE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.FinaftaMulti
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep Out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS OR COMMENTS? 305-805-3456 Monday-Friday (9 a.m.- 5 p.m. EST) www.efficientlabs.com
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 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 for teething in children under 2 years of age 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API