Asperflex 24hrs
FDA Label NDC 71399-3884

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Akron Pharma Inc. for the product Asperflex 24hrs (NDC 71399-3884). 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 ingredient, purpose, dosage and administration, warnings, idications and usage, otc - when using, do not use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

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

Purpose

Temporarily relieves minor pain.

Dosage And Administration

Directions Adults and children over 12 years:

  • clean and dry affected area
  • carefully remove backing from patch starting at corner
  • apply sticky side of patch to affected area
  • use one patch for up to 24 hours. Discard patch after single use. Children under 12 years of age: consult a physician.

Warnings

For external use only.

Idications And Usage

Uses: Temporaily relieves minor pains.

Otc - When Using

When using this product

  • use only as directed
  • read and follow all directions and warnings on this carton
  • do not allow contact with the eyes
  • do not use at the same time as other topical analgesics
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not microwave
  • 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.

Do Not Use

  • 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center right away 800-222-1222

Other Safety Information

Other Safety Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive Ingredient

Inactive Ingredients

Alicyclic Hydrocarbon Resin, Mineral Oil, Polyester film, Silicone –coated polyester film and styrene isoprene styrene block copolymer

NDC: 71399-3884-6

Package size: 6 Patches

Questions?

Please Call 1(877) 225-6999

Manufactured for:
Akron Pharma, Inc.
Fairfield, NJ 07004
Manufactured in U.S.A

Re-Lieved Lidocaine 4% Patch

Single Pouch (Single Pouch)

Single Pouch (Single Pouch)

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