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| Product NDC Code | 24689-124 | ||||
|---|---|---|---|---|---|
| Drug Name | Lidocaine 5% |
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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, TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1366789 | ||||
| Application Number | M015 | ||||
| Labeler Name | Apnar Pharma LP | ||||
| 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.Lidocaine 5% w/w
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 50 miligrams/gram per application
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Benzyl Alcohol, Carbopol 940 (Carbomer 940), Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, and Vitamin E Acetate (Alpha Tocophferol Acetate)
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.USAGE Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day. Children under 12 years of age: Consult a doctor
Purpose
Information about the drug product’s indications for use.Local Anesthetic Uses Temporarily relieves pain and itching due to anorectal disorders
Spl product data elements
Usually a list of ingredients in a drug product.Lidocaine 5% Lidocaine POLYSORBATE 80 HYDROGENATED SOYBEAN LECITHIN ISOPROPYL MYRISTATE BENZYL ALCOHOL CARBOMER 940 PROPYLENE GLYCOL ALPHA-TOCOPHEROL ACETATE WATER TROLAMINE 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.NDC 24689-124-01 Lidocaine 5% Anorectal Cream Apnar Pharma LP Net.Wt 30 grams Lidocaine cream caron
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.Rectal bleeding occurs Condition worsens or does not improve within 7 days Allergic reaction occurs Redness, irritation, swelling, pain or other symptoms begin or increase Symptoms clear up and return within a few days
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.If swallowed, get medical help or contact 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.Store at room temperature 20-25°C (68-77°F); Excursions permitted 15-30°C (59-86°F) [see USP Controlled Room Temperature].
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.DIRECTIONS When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day. Children under 12 years of age: Consult a doctor
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.When using this product Avoid contact with eyes Do not exceed recommended dosage unless directed by 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