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| Product NDC Code | 80425-0351 | ||||
|---|---|---|---|---|---|
| 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 | 1421893 | ||||
| Application Number | part348 | ||||
| Labeler Name | Advanced Rx Pharmacy of Tennessee, LLC | ||||
| 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% 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 Adult and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day. Children under 2 years of age: Consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Benzyl Alcohol, Carbopol 940, Hydrogenated Lecithin, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine and Vitamin E 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 temporarily relieves pain and itching due to minor cuts minor scrapes minor burns sunburn minor skin irritation insect bites
Purpose
Information about the drug product’s indications for use.Purpose Topical anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Lidocaine Lidocaine BENZYL ALCOHOL CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) HYDROGENATED SOYBEAN LECITHIN POLYSORBATE 80 PROPYLENE GLYCOL WATER TROLAMINE .ALPHA.-TOCOPHEROL ACETATE 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.label 1
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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use in or near the eyes in large quantities, particularly over raw or blistered areas
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. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 800-936-3088
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 and ask a doctor if allergic reaction occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.How Supplied/Storage and Handling Lidocaine 4% Cream is supplied in: 15g tube NDC: 80425-0351-01 Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].
Storage and handling
Information about safe storage and handling of the drug product.Other Information May be applied under occlusive dressing. Store at room temperature, 20–25°C (68–77°F) Excursions permitted 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 For external use only. Do not use in or near the eyes in large quantities, particularly over raw or blistered areas Stop use and ask a doctor if allergic reaction occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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