NDC 50804-838 Goodsense Pain Relief

Lidocaine

NDC Product Code 50804-838

NDC 50804-838-05

Package Description: 5 POUCH in 1 CARTON > 1 PATCH in 1 POUCH

NDC Product Information

Goodsense Pain Relief with NDC 50804-838 is a a human over the counter drug product labeled by Geiss, Destin & Dunn, Inc. The generic name of Goodsense Pain Relief is lidocaine. The product's dosage form is patch and is administered via topical form.

Labeler Name: Geiss, Destin & Dunn, 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.

Goodsense Pain Relief 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.

  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • ALCOHOL (UNII: 3K9958V90M)
  • DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)
  • KAOLIN (UNII: 24H4NWX5CO)
  • METHYLPARABEN (UNII: A2I8C7HI9T)

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: Geiss, Destin & Dunn, Inc
Labeler Code: 50804
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: 02-21-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Goodsense Pain Relief Product Label Images

Goodsense Pain Relief 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 ingredient PurposeLidocaine 4%..................................................................Topical anesthetic.

Otc - Purpose

  • Usetemporarily relieves minor pain

Warnings

WarningsFor external use only

Otc - Do Not Use

  • Do not usemore than 1 patch on your body at a time or on cut, irritated or swollen skinat the same time as other topical analgesicson puncture woundsfor more than one week without consulting a doctor

Otc - When Using

  • When using this productuse only as directed. Read and follow all directions and warnings on this label.do not allow contact with the eyesdo not bandage tightly or apply local heat (such as heating pads) to the area of usediscontinue use at least 1 hour before a bath or showerdo not use immediately after a bath or showerdispose of used patch in matter that always keeps product away from children or 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 ifcondition worsensredness is presentsymptoms persist for more than 7 days or clear up and occur again within a few daysirritation developsyou experience signs of skin injury, such as pain, 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. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Indications & Usage

  • Directionsadults and children over 12 years:clean and dry affected arearemove backing from patch by firmly grasping both ends and gently pulling until backing separates in middlecarefully remove smaller portion of backing from patch and apply exposed portion of patch to affected areaonce exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected areause 1 patch for up to 12 hourschildren 12 years or younger: ask doctor

Storage And Handling

  • Other informationstore at room temperature 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredientsalcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, tartaric acid, titanium dioxide

Dosage & Administration

Distributed by:Geiss, Destin & Dunn, Inc.Peachtree City, GA 30269Made in China

* Please review the disclaimer below.

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