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| Product NDC Code | 27854-333 | ||||
|---|---|---|---|---|---|
| Drug Name | Flanax back pain relief |
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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 | Belmora 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 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: • Clean and dry affected area • Carefully remove backing film from patch • Apply one patch to affected area • Do not use more than 2 patches in 24 hours unless, directed by a doctor. Children under 12 years : ask a doctor. How to apply • Remove backing from patch by firmly grasping both ends and gently pull backing to separate it in the middle. • Carefully remove one portion of backing from patch and apply exposed portion of patch to affected area. • Once exposed portion of patch is positioned, remove remaining backing to completely apply patch to affected area. IMAGE
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Kaolin, Titanium Dioxide, Polysorbate 80, Propylene Glycol, Tartaric Acid, Polyacrylic Acid, Polyvinylpyrrolidone K90, Methylparaben, Propylparaben, Water
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 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.Flanax Back Pain Relief Lidocaine LIDOCAINE LIDOCAINE GLYCERIN SODIUM POLYACRYLATE (2500000 MW) DIHYDROXYALUMINUM AMINOACETATE EDETATE DISODIUM KAOLIN TITANIUM DIOXIDE POLYSORBATE 80 PROPYLENE GLYCOL TARTARIC ACID POLYACRYLIC ACID (250000 MW) POVIDONE K90 METHYLPARABEN PROPYLPARABEN WATER
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.Packaging IMAGE
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
LONGER LASTING PAIN RELIEF • For back, neck, leg & arm pain relieving ointment on a breathable adhesive pad Questions/Comments? www.flanax.com Call 1 888 779 2877 9AM-5PM EST Distributed by: Belmora LLC 2011 Crystal Dr. Suite 400, Arlington, VA 22202
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.
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 • More than 1 patch on your body at a time or on cut, irritated or swollen skin • On puncture wounds • For more than one week without consulting a doctor When using this product • Use only as directed. Read and follow all directions and warnings on this pouch • Rare cases of serious burns have been reported with products of this type • Do not apply to wounds or damaged, broken or irritated skin • Do not allow contact with the eyes and mucous membranes • Do not bandage tightly or apply local heat (such as heating pads) to the area of use • Do not use at the same time as other topical analgesics • Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug products that can produce serious adverse effects if a child or pet chews or ingests this patch Stop use and ask a doctor if • Condition worsens • Redness is present • Irritation develops • Symptoms persist for more than 7 days or clear up and occur again within a few days • You experience signs of skin injury, such as pain, swelling, or blistering 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 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