NDC 72189-148 Transderm Iq

Transderm Iq

NDC Product Code 72189-148

NDC 72189-148-15

Package Description: 15 PATCH in 1 BOX > 1 g in 1 PATCH

NDC Product Information

Transderm Iq with NDC 72189-148 is a a human over the counter drug product labeled by Direct Rx. The generic name of Transderm Iq is transderm iq. The product's dosage form is patch and is administered via transdermal form.

Labeler Name: Direct Rx

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.

Transderm Iq 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.

  • MENTHOL, UNSPECIFIED FORM 40 mg/g
  • 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.

  • 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.

  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.

Product Labeler Information

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

Labeler Name: Direct Rx
Labeler Code: 72189
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: 04-07-2021 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.

Transderm Iq Product Label Images

Transderm Iq 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

Otc - Active Ingredient

Active ingredients:Lidocaine HCL 4%Menthol 4%

Otc - Purpose

Purpose:Topical Anesthetic

Indications & Usage

Uses:For the temporary relief of pain

Warnings

Warnings:For external use

Otc - Do Not Use

Do not use:More than 1 patch on your body at a time or on cut, iritated or swollen skin.

On puncture wounds

For more than 1 week without consulting a doctor

Otc - When Using

When using this product:Use only as directed. Read and follow all directions and warnings on this label.

Rare cases of serious burns have been reported with products of this type.

Do not apply to wounds 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 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.

Otc - Stop Use

Stop use and ask a doctor if:Condition worsens

Redness is present

Irritation developes

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.

Pregnancy

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

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.

Dosage & Administration

Directions:Adults and children over 12 years:Clean and dry the affected area.

Open pouch and remove one patch.

Remove the protective film from the patch and apply patch to the affected area.

Reseal pouch containing unused patches after each use.

Use 1 patch for up to 12 hours.
Children 12 years or younger:Ask a doctor

Other Safety Information

Other Information:Avoid storing product in direct sunlight

Protect product from excessive mositure

Inactive Ingredient

Other Ingredients:Acrylic Adhesive

* Please review the disclaimer below.