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| Product NDC Code | 59316-899 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Biofreeze ultraflex |
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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 | ||||||
| Application Number | M017 | ||||||
| Labeler Name | RB Health (US) 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% Purpose: Pain Relieving Patch
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 affected area, cut open pouch and remove patch from protective film by first peeling back center film. Apply exposed patch to affected area. Carefully remove remaining film while pressing the patch to skin and leave in place for up to 8 hours. (see images on carton) use 1 patch at a time and not more than 3 to 4 times daily children under 12 years of age: consult a physician wash hands after use with cool water
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Butylated Hydroxytoluene, Glyceryl Hydrogenated Rosinate, Mineral Oil, Polyisobutylene, 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 pain
Purpose
Information about the drug product’s indications for use.Uses Uses For the temporary relief of pain
Spl product data elements
Usually a list of ingredients in a drug product.Biofreeze Ultraflex Lidocaine GLYCEROL ESTER OF HYDROGENATED ROSIN BUTYLATED HYDROXYTOLUENE LIDOCAINE LIDOCAINE POLYISOBUTYLENE (55000 MW) STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER 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.Label
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at 20-25°C (68-77°F) store in a cool dry place away from direct sunlight
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? 1-866-682-4639
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 more than 1 patch on your body at a time or with other topical anesthetics at the same time on wounds, damaged skin, rashes, or swollen skin with a heating pad or apply local heat to the area of use in large quantities, particularly over raw surfaces or blistered areas When using this product use only as directed do not bandage tightly avoid contact with the eyes or on mucous membranes dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch. Stop use and ask a doctor if the condition for which this preparation is used persists or if a rash, redness or irritation develops condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within few days you experience pain, swelling or blistering of the skin 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