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| Product NDC Code | 58980-823 | ||||||
|---|---|---|---|---|---|---|---|
| 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 | 1534792 | ||||||
| Application Number | part346 | ||||||
| Labeler Name | STRATUS PHARMACEUTICALS 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 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.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. To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients acrylamide, allantoin, aloe vera extract, benzyl alcohol, C12-15 alkyl benzoate, carbomer, isohexadecane, polysorbate 80, propylene glycol, purified water, sodium acryloyldimethyl taurate, sodium laureth sulfate, soy lecithin and tocopheryl 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.Uses Helps relieve the pain, itching, and burning associated with other rectal disorders.
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 LIDOCAINE LIDOCAINE ACRYLAMIDE ALLANTOIN ALOE VERA LEAF BENZYL ALCOHOL ALKYL (C12-15) BENZOATE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE ISOHEXADECANE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM ACRYLOYLDIMETHYLTAURATE SODIUM LAURETH-3 SULFATE LECITHIN, SOYBEAN .ALPHA.-TOCOPHEROL ACETATE
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.PRINCIPAL DISPLAY PANEL - 14.17 g Tube Box STRATUS PHARMACEUTICALS INC NDC 58980-823-05 Net WT. 0.5 oz. / 14.17 g LIDOCAINE CREAM 5% ANORECTAL CREAM PRINCIPAL DISPLAY PANEL - 14.17 g Tube Box
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Distributed By: Stratus Pharmaceuticals, Inc.,Miami, FL 33186
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 of children. If swallowed, get medical help or contact Poison Control Center immediately.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
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 "Methemoglobinemia Warning" use of this product may cause; a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used the product before. Stop use and seek immediate medical attention if the following develops: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy. If pregnant or breast feeding, ask a health provider before use. Keep out of reach of of children. If swallowed, get medical help or contact Poison Control Center immediately.
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