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| Product NDC Code | 83365-003 | ||||
|---|---|---|---|---|---|
| Drug Name | Lidocaine |
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| Type | Generic | ||||
| 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 | Sichuan Gumo Brand Management Co.,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 Ingredient Lidocaine 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 Adults : When practical , cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blottingwith toilet tissue or a soft cloth , before application of this product. Apply up to 6 times a day, Children up under 12 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimenthyl Isosorbide, Disodium EDTA , Hydrogenated Polydece, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Acetate, Trideceth-6, Triethanolamine
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 temporary relief of local and anorectal discomfort associated with anorectal disorder or inflammation
Purpose
Information about the drug product’s indications for use.Purpose Local Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.LIDOCAINE LIDOCAINE PROPYLENE GLYCOL WATER SODIUM POLYACRYLATE (2500000 MW) ALLANTOIN EDETATE DISODIUM ANHYDROUS HYDROGENATED POLYDECENE TYPE I LECITHIN, SOYBEAN NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE TROLAMINE ALPHA-TOCOPHEROL TRIDECETH-6 ALOE VERA LEAF CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE DIMETHYL ISOSORBIDE BENZYL ALCOHOL CHOLESTEROL 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 Display Panel 83365-003-01
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 Incase of accidental ingestion , seek medical attention immediately
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 n/a
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 exceed the recommended daily dosage unless directed by a doctor. certain persons can develop allergic reactions to ingredients in this product. do not put this product into the rectum by using finger or any medical device or applicator.
Storage and handling
Information about safe storage and handling of the drug product.Other Information keep away from direct sunlight or heata. store in room temperature ( 59-86 F/15-30 C )
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 extemal use only )
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