NDC 70512-014 Lidocaine 4% Patch

Lidocaine 4%

NDC Product Code 70512-014

NDC 70512-014-30

Package Description: 6 POUCH in 1 BOX > 5 g in 1 POUCH

NDC Product Information

Lidocaine 4% Patch with NDC 70512-014 is a a human over the counter drug product labeled by Sola Pharmaceuticals. The generic name of Lidocaine 4% Patch is lidocaine 4%. The product's dosage form is patch and is administered via topical form.

Labeler Name: Sola Pharmaceuticals

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.

Lidocaine 4% Patch 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/g

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.

  • FLAX SEED (UNII: 4110YT348C)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • ACRYLIC ACID (UNII: J94PBK7X8S)

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: Sola Pharmaceuticals
Labeler Code: 70512
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: 05-24-2021 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.

Lidocaine 4% Patch Product Label Images

Lidocaine 4% Patch 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 Ingredients

Lidocaine HCL 4%

Purpose

Topical Anesthetic

Uses

For the temporary relief of pain

Warnings

For external use only

Otc - Do Not Use

  • Do not use:More than 1 patch at a timeOn wounds or damaged skinWith a heating padIf you are allergic to any ingredients of this product

Otc - When Using

  • When using this product:Use only as directedAvoid contact with the eyes, mucous membranes, or rashesDo not bandage tightly

Otc - Stop Use

  • Stop use and ask a doctor if:Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blisteringConditions worsenSymptoms persist for more than 7 daysSymptoms clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 12 years of age or over:Clean and dry the affected areaOpen pouch and remove one patchApply 1 patch at a time to affected area; not more than 3 to 4 times dailyReseal pouch containing unused patches after each useRemove patch from the skin after at most 8-hour applicationChildren under 12 years of age:Consult a doctor

Other Information

  • Avoid storing product in direct sunlightProtect product from excessive moisture

Other Ingredients

Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

* Please review the disclaimer below.