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| Product NDC Code | 82598-101 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Alivio |
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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 | TRANSDERMAL | ||||||
| Dosage Form | PATCH | ||||||
| RxCUI drug identifier | 1737778 | ||||||
| Application Number | M017 | ||||||
| Labeler Name | Amerise Pharmaceuticals 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% .................................... Topical Anesthetic
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 remove backing from patch by firmly grasping both ends and gently pulling until back separates in middle use 1 patch for up to 12 hours Children 12 years or younger; ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients alpha-tocopherol acetate, aluminum hydroxide, aluminum silicate, butylated hydroxytoluene, butyl rubber, isoprene rubber, mineral oil, polyisobutylene, rosin, silicon dioxide, styrene/isoprene/styrene block, titanium dioxide
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.Temporarily relieves minor pain
Spl product data elements
Usually a list of ingredients in a drug product.Alivio Lidocaine ALPHA-TOCOPHEROL ACETATE ALUMINUM HYDROXIDE ALUMINUM SILICATE BUTYLATED HYDROXYTOLUENE MINERAL OIL ROSIN SILICON DIOXIDE STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER TITANIUM DIOXIDE ISOPRENE ISOBUTYLENE POLYISOBUTYLENE (1000 MW) 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.Carton Image Pouch Image
Lidocaine Carton - 3 pack
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 in US by: Amerise Pharmaceuticals LLC 6 Corporate Dr, Cranbury, NJ 08512 Customer Care NO.: 609-721-9587 Email: [email protected]
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 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 warning on this carton rare cases of serious burns have been reported with products of this type do not apply to wonds 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 keep 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 a transient buring sensation may occur upon applicaiton but generally disappears in several day if a severe buring sensation occurs, discontinue use immediately Stop use and ask a doctor if condition worsens redness is present irritation develops sypmtoms 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.
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