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| Product NDC Code | 81777-106 | ||||
|---|---|---|---|---|---|
| Drug Name | Xesso neo |
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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, TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| Application Number | M013 | ||||
| Labeler Name | PREMIUM NATURAL COSMETICS 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 Ingredient Benzocaine 5%
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 Apply to the affected area (one spray). Allow to remain in place for at least 15 seconds then spit out. May be repeated every two hours as needed or as directed by a health care professional.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Alcohol, FD&C RED NO. 40, Glycerinm, Natural Flavors, PEG-40 Hydrogenated Castor Oil, Polyvinylpryyolidone (PVP), Sucralose), 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.Use Section For temporary relief of minor throat irritation, pain, and sore throat.
Purpose
Information about the drug product’s indications for use.Purpose Oral Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Xesso Neo Benzocaine BENZOCAINE BENZOCAINE POVIDONE, UNSPECIFIED POLYOXYL 40 CASTOR OIL SUCRALOSE GLYCERIN WATER ALCOHOL 95% FD&C RED NO. 40
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.PDP and Back Panel PDP
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 section Keep this and all drugs out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Tamper-Evident: Do not use if tamper evident seal on the outside of the container is broken or missing. Store at room temperature 20 - 25 C (68 - 77 F)
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.Warning Section Warning 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 the blood. 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 energy. Sore Throat Warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. For adult use only. Keep this and all drugs out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center right away. As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product. Stop use and consult a doctor if difficulty in breathing occurs, swelling or fever develops, or if sore mouth or throat symptoms do not improve within 7 days. Do not exceed the recommended dosage. Keep away from fire or flames. Keep out of reach of children section Keep this and all drugs out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center right away.
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