Alivio Patch
FDA Label NDC 82598-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerise Pharmaceuticals Llc for the product Alivio (NDC 82598-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, use, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Lidocaine 4% .................................... Topical Anesthetic

Use

Temporarily relieves minor pain

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.

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 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

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