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| Product NDC Code | 69452-409 | ||||
|---|---|---|---|---|---|
| Drug Name | Pain relief patch |
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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 | M017 | ||||
| Labeler Name | Bionpharma Inc. | ||||
| Packages |
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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 over: Clean and dry affected area ■ Apply immediately upon removal from pouch ■ Peel off the first liner and apply exposed patch to affected area ■ Peel off second liner while applying the rest of patch ■ Remove patch after 24 hours ■ Discard patch after single use. ■ Children under 12 years of age: Consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients alicyclic hydrocarbon resin, mineral oil, polyester film, silicone-coated polyester film, styrene isoprene, styrene block copolymer.
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 For the temporary relief of 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.pain relief patch Lidocaine 4% HYDROGENATED C6-20 POLYOLEFIN (100 CST) LIDOCAINE LIDOCAINE STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (STYRENE/ISOPRENE 15/85) MINERAL 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.Carton Label NDC 69452-409-04 maximum strength a+ health TM pain relief lidocaine 4% patch topical analgesic • desensitizes aggravated nerves • odor free, thin & flexible • no-mess, single use application 24 hours 6 Patches 2.91" x 2.17" carton
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.Read directions and warning before use KEEP OUT OF REACH OF CHILDREN AND PETS Made in USA from Domestic and Imported Components Distributed by: Bionpharma Inc. Princeton, NJ 08540 L0000735 R0623
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 you are allergic to any active or inactive ingredients of this product ■ On wounds or damaged, irritated or sensitive skin ■ More than one patch on your body at a time or with other topical analgesics at the same time ■ For more than one week without consulting a doctor ■ With a heating pad ■ If pouch is damaged or opened.
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 chewed or swallowed, get medical help or contact a Poison Control Center right away (800-222-1222).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
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 ■ Symptoms persist for more than seven days or clear up and occur again within a few days ■ Localized skin reactions such as rash, pain, itching, redness, irritation, swelling or blistering occur where the product was applied.
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 ■ Avoid contact with the eyes ■ Use only as directed ■ Read and follow all directions and warnings on this package ■ Do not bandage tightly or apply local heat to the area of use ■ Do not reuse patch ■ Keep this product away from pets and children. Used patches still contain the drug product that can produce serious adverse effect if a child or pet chews or ingests this 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.Other information Store in a clean, dry place away from direct sunlight. Store in original unopened pouch protected from 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 ■ If you are allergic to any active or inactive ingredients of this product ■ On wounds or damaged, irritated or sensitive skin ■ More than one patch on your body at a time or with other topical analgesics at the same time ■ For more than one week without consulting a doctor ■ With a heating pad ■ If pouch is damaged or opened. When using this product ■ Avoid contact with the eyes ■ Use only as directed ■ Read and follow all directions and warnings on this package ■ Do not bandage tightly or apply local heat to the area of use ■ Do not reuse patch ■ Keep this product away from pets and children. Used patches still contain the drug product that can produce serious adverse effect if a child or pet chews or ingests this patch Stop use and ask a doctor if ■ Condition worsens ■ Symptoms persist for more than seven days or clear up and occur again within a few days ■ Localized skin reactions such as rash, pain, itching, redness, irritation, swelling or blistering occur where the product was applied. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children and pets If chewed or swallowed, get medical help or contact a Poison Control Center right away (800-222-1222).
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