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| Product NDC Code | 72559-016 | ||||
|---|---|---|---|---|---|
| Drug Name | Curist lidocaine maximum strength |
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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 | PATCH | ||||
| RxCUI drug identifier | 1737778 | ||||
| Application Number | part348 | ||||
| Labeler Name | Little Pharma, 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 4%
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 and children 12 years of age and older: clean and dry the affected area open pouch and remove one patch remove the protective backing from the patch starting at the corner apply sticky side of patch to affected area reseal pouch containing unused patches after each use use one patch for up to 12 hours discard patch after single use children under 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acrylic adhesive, alcohol, black pepper extract
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 temporarily relieves minor pain
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.Curist Lidocaine Maximum Strength Lidocaine BLACK PEPPER ACRYLIC ACID ALCOHOL 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.Curist Lidocaine Patch Maximum Strength Lidocaine 4% Patch Topical Anesthetic Temporary relief of pain: back, neck, shoulders, knees, elbows 20 PATCHES 3 in x 5 in (7.6 cm x 12.7 cm) each Lidocaine Patch 01-2022
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: Little Pharma, Inc. New York, NY 10023 Made in USA With Globally Sourced Ingredients
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 on raw surfaces, blistered areas, wounds or other damaged skin with a heating pad more than one patch on your body at a time with other topical anagesics
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? 1-844-243-1241
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 pain, swelling, blistering or other irritation occurs where patch was applied condition worsens symptoms last more than 7 days condition clears up and occurs again within a few days
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 use only as directed avoid contact with the eyes do not bandage tightly
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store in a clean, dry place outside of direct sunlight protect product from excessive moisture
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 on raw surfaces, blistered areas, wounds or other damaged skin with a heating pad more than one patch on your body at a time with other topical anagesics When using this product use only as directed avoid contact with the eyes do not bandage tightly Stop use and ask a doctor if pain, swelling, blistering or other irritation occurs where patch was applied condition worsens symptoms last more than 7 days condition clears up and occurs again within a few days If pregnant or breastfeeding, ask a health professional before use. 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