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| Product NDC Code | 81777-105 | ||||
|---|---|---|---|---|---|
| Drug Name | Xesso strawberry rear comfort glide 4% lidocaine |
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| Type | Brand | ||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | RECTAL | ||||
| Dosage Form | GEL | ||||
| Application Number | M015 | ||||
| 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 Lidocaine 4%
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 Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply externally to the affected area up to 6 times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Inactive Ingredients: Carboxymethylcellulose Sodium, Diazolidinyl urea, Glycerin, Isopentyldiol, Methylparaben, Propylparaben, Water, Natural Flavor.
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 For temporary relief of pain, soreness, or burning in the perianal area.
Purpose
Information about the drug product’s indications for use.Purpose Anorectal
Spl product data elements
Usually a list of ingredients in a drug product.Xesso Strawberry Rear Comfort Glide 4% Lidocaine Lidocaine METHYLPARABEN PROPYLPARABEN GLYCERIN DIAZOLIDINYL UREA CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM ISOPENTYLDIOL LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS WATER
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.Principle Display Panel PDP
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor section As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.
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 Keep out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop Use Certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
Storage and handling
Information about safe storage and handling of the drug product.Other information Other Information: • Store at room temperature 20 - 25°C (68 - 77°F). • Do not use if tamper evident seal on the outside of the container is broken or missing.
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 Warnings: • For external use only. Do not use this product with a mechanical device. • Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor. • Do not exceed the daily recommended dosage. • Do not apply onto cracked or broken skin. • In case of any bleeding, discontinue use and consult a doctor.
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