NDC 71399-3884 Asperflex 24hrs

Lidocaine Patch 4%

NDC Product Code 71399-3884

NDC 71399-3884-6

Package Description: 6 POUCH in 1 CARTON > 1 PATCH in 1 POUCH > 1 PATCH in 1 PATCH

NDC Product Information

Asperflex 24hrs with NDC 71399-3884 is a a human over the counter drug product labeled by Akron Pharma Inc.. The generic name of Asperflex 24hrs is lidocaine patch 4%. The product's dosage form is patch and is administered via topical form.

Labeler Name: Akron Pharma Inc.

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Asperflex 24hrs Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • LIDOCAINE 40 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MINERAL OIL (UNII: T5L8T28FGP)
  • STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Akron Pharma Inc.
Labeler Code: 71399
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-18-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Asperflex 24hrs Product Label Images

Asperflex 24hrs Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling 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 areacarefully remove backing from patch starting at cornerapply sticky side of patch to affected areause 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 productuse only as directedread and follow all directions and warnings on this cartondo not allow contact with the eyesdo not use at the same time as other topical analgesicsdo not bandage tightly or apply local heat (such as heating pads) to the area of usedo not microwavedispose 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 worsensredness is presentirritation developssymptoms persist for more than 7 days or clear up and occur again within a few daysyou 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: 71399-3884-6Package size: 6 Patches

Questions?

Please Call 1(877) 225-6999Manufactured for:
Akron Pharma, Inc.
Fairfield, NJ 07004
Manufactured in U.S.A

* Please review the disclaimer below.