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| Product NDC Code | 69993-425 | ||||
|---|---|---|---|---|---|
| Drug Name | Blue-emu lidocaine dry |
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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 | NFI, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients 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 over 12 years of age: Apply patch to affected area every 8 to 12 hours. Children 12 years or younger: Consult a physician before use. Instructions for Use • clean and dry affected area • cut open pouch and remove the patch • remove clear protective liner from the patch • apply to affected area no more than three (3) times per day • leave in place for up to 8 but no more than 12 hours • wash hands thoroughly after applying or removing patch • some individuals may not experience pain relief until several minutes or hours after applying a patch • do not use other local anesthetic products in addition to Lidocare
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Crospovidone, menthoxypropanediol, non-woven backing fabric, polyester film, non-latex rubber based adhesive, vanillyl butyl ether.
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 For the temporary relief of 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.Blue-Emu Lidocaine Dry Lidocaine Lidocaine Lidocaine Isopropyl Alcohol Heptane Emu Oil
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 - 3 Patch Carton Label RELIEF YOU CAN WEAR™ BLUE-EMU ® No Mess! Odor Free + Emu Oil 4% Lidocaine Dry-Patch AMERICA'S #1 ODOR FREE EMU OIL FORMULA 3 PATCHES 2.5"X 6" Lidocaine-01
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.DISTRIBUTED BY: NFI CONSUMER PRODUCTS 501 Fifth Street • Bristol, TN 37620 Toll Free: 800-432-9334
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 if pouch is damaged or opened. Do not use • on large areas of the body or on cut, irritated skin • on open wounds or sensitive skin • for more than one week without consulting a doctor • do not use more than one patch at a time • do not use if you are allergic to lidocaine or any of the inactive ingredients listed below.
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 and pets. If swallowed, get medical help or contact a Poison Control Center right away.
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 • condition worsens • rash, itching or skin irritation develops • symptoms persist for more than 7 days or clear up and occur 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. Read and follow all directions and warnings on this package. • do not allow contact with the eyes • do not bandage or apply local heat (such as heating pads) to the area of use • do not reuse patch.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding , ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Storage Information • protect from freezing and excessive heat • store at 68°-77°F (20°-25°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 For external use only. Do not use if pouch is damaged or opened. Do not use • on large areas of the body or on cut, irritated skin • on open wounds or sensitive skin • for more than one week without consulting a doctor • do not use more than one patch at a time • do not use if you are allergic to lidocaine or any of the inactive ingredients listed below. When using this product • use only as directed. Read and follow all directions and warnings on this package. • do not allow contact with the eyes • do not bandage or apply local heat (such as heating pads) to the area of use • do not reuse patch. Stop use and ask a doctor if • condition worsens • rash, itching or skin irritation develops • symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children and pets. 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