NDC 73638-901 Niravi 24 Hours Lidocaine 4 % Patch

Lidocaine

NDC Product Code 73638-901

NDC CODE: 73638-901

Proprietary Name: Niravi 24 Hours Lidocaine 4 % Patch What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Lidocaine What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to help reduce itching and pain from certain skin conditions (such as scrapes, minor skin irritations, insect bites). It may also be used to help relieve nerve pain after shingles (infection with herpes zoster virus). Lidocaine belongs to a class of drugs known as local anesthetics. It works by causing a temporary loss of feeling in the area where you apply the patch.

NDC Code Structure

  • 73638 - Sparsha Pharma Usa, Inc.
    • 73638-901 - Niravi 24 Hours Lidocaine 4 % Patch

NDC 73638-901-01

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

NDC Product Information

Niravi 24 Hours Lidocaine 4 % Patch with NDC 73638-901 is a a human over the counter drug product labeled by Sparsha Pharma Usa, Inc.. The generic name of Niravi 24 Hours Lidocaine 4 % Patch is lidocaine. The product's dosage form is patch and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1737778 and 2560250.

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.

Niravi 24 Hours 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.


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)
  • HYDROGENATED C6-20 POLYOLEFIN (100 CST) (UNII: 39EYQ1W9RB)
  • STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (STYRENE/ISOPRENE 15/85) (UNII: 1SSZ6HXE7P)

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: Sparsha Pharma Usa, Inc.
Labeler Code: 73638
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: 06-30-2021 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".

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Niravi 24 Hours Lidocaine 4 % Patch Product Label Images

Niravi 24 Hours 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 Ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Use

For the temporary relief of minor pain.

Warnings

For External Use Only

Do Not Use

• If you are allergic to any active or inactive ingredients of this product• On wounds or damaged, irritated or sensitive skin• With any other topical anesthetic• For more than one week without consulting a doctor• With a heating pad• If pouch is damaged or opened.

When Using This Product

• Do not allow contact with the eyes• Use only as directed• Read and follow all directions and warnings on this package• Do not bandage tightly or apply local heat to the area of use• Do not reuse patch• Keep this product away from pets and children. Used patches still contains the drug product that can produce serious adverse effect if child or pet chews or ingest this patch.

Stop Use And Ask A Doctor If

• Condition worsens• Symptoms persist for more than seven days or clear up and occur again within a few days• Localized skin reactions occur such as rash, pain, itching, redness, irritation, swelling or blistering where the product was applied.

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 and pets. If chewed or swallowed, get medical help or contact a Poison Control Center right away (800-222-1222).

Directions

Adults and children 12 years of age and over: Clean and dry affected area. Apply immediately upon removal from pouch. Peel off the first liner and apply exposed patch to affected area. Peel off second liner while applying the rest of patch. Remove patch after 24 hours. Do not expose area to heat.Children under 12 years of age: Consult a doctor.

Inactive Ingredients

Alicyclic hydrocarbon resin, mineral oil, polyester film, silicon-coated polyester film and styrene isoprene styrene block copolymer.

Other Information

.Store in a clean, dry place away from direct sunlight. Store in original unopened pouch. protected from moisture.

Questions ?

Customer Care Helpline 844-348-5423 Monday- Friday 8:30 a.m – 4:30 p.m PST

Package Label

Carton Label NDC 73638-901-01Pouch Label

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