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| Product NDC Code | 76092-201 | ||||
|---|---|---|---|---|---|
| Drug Name | Smart numb lidocaine cream |
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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 | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1366789 | ||||
| Application Number | M015 | ||||
| Labeler Name | M.J. Winston International, Ltd. | ||||
| 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 Lidocaine 5% local anesthetic active
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.dosage administration
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aacrylates, Allantoin, Arnice Montana Flower Extract, Deionized Water, Dimethyl Isosorbide, Emu Oil, Ethylhexyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Polydecene, Menthol, Phenoxythanol, Propylene Glycol, Sodium Polyacrylate, Tetrasodium Edta, Tocopheryl Acetate, Trideceth-6 inactive
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 the temporary relief of pain, burning, and soreness associated with anorectal discomfort or inflammation. indication
Purpose
Information about the drug product’s indications for use.Use For the temporary relief of pain, burning, and soreness associted with anorectal discomfort or inflammation. use
Spl product data elements
Usually a list of ingredients in a drug product.SMART Numb Lidocaine Cream lidocaine PROPYLENE GLYCOL ARNICA MONTANA FLOWER MENTHOL TRIDECETH-6 ETHYLHEXYLGLYCERIN PHENOXYETHANOL SUNFLOWER OIL EDETATE SODIUM SODIUM POLYACRYLATE (2500000 MW) HYDROGENATED POLYDECENE (1500 CST) WATER DIMETHYL ISOSORBIDE EMU OIL ALLANTOIN .ALPHA.-TOCOPHEROL ACETATE, D- ETHYLHEXYL PALMITATE ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) LIDOCAINE LIDOCAINE
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.package label principal
Instructions for use
Information about safe handling and use of the drug product.Directions Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. For products for external use only. Apply up to 6 times a day. Children under 12 years of age: consult a doctor. directions
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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store at 59F to 86F (15C to 30C). Keep away from direct sunlight. other info
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or concerns? Contact [email protected] or 714-582-2715. questions
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product Do not excceed recommended dosage unless directed by a doctor. when using this product
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 For external use only. Stop use and ask a doctor if the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop. If pregnant or breast-feeding, ask a health professional before use. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Keep out of reach of children. WARNINGS
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