NDC 72988-0007 Hot Pap Cataplasma

Methyl Salicylate, Vanillyl Nonylamide

NDC Product Code 72988-0007

NDC 72988-0007-1

Package Description: 13.4 g in 1 POUCH

NDC Product Information

Hot Pap Cataplasma with NDC 72988-0007 is a a human over the counter drug product labeled by Lydia Co., Ltd.. The generic name of Hot Pap Cataplasma is methyl salicylate, vanillyl nonylamide. The product's dosage form is patch and is administered via transdermal form.

Labeler Name: Lydia Co., Ltd.

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.

Hot Pap Cataplasma 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.

  • METHYL SALICYLATE 58.3 mg/13.4g

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.

  • THYMOL (UNII: 3J50XA376E)
  • KAOLIN (UNII: 24H4NWX5CO)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Lydia Co., Ltd.
Labeler Code: 72988
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: 03-29-2019 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.

Hot Pap Cataplasma Product Label Images

Hot Pap Cataplasma 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

Methyl salicylateVanillyl nonylamide

Inactive Ingredient

KaolinGlycerinLiquid paraffinGelatinTitanium oxideCarboxymethylcellulose sodiumZinc oxideMethoxyethylene maleicanhydride copolymerPolybuteneCitric acid hydrateSodium polyacrylateThymolButyl parabenButylated hydroxy toluenePolysorbate 60Isopropyl myristateNatural rubber latexPurified waterNonwoven fabricPolyester film

Otc - Purpose

Topical AnalgesicTemporarily relieves minor pain associated with - muscular pain - joint pain - backache - bruise - sprain

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily.Children under 12 years of age: do not use, consult a doctor

For easy application: partially peel back protective film and apply exposed patch to the site of pain.

Carefully remove remaining film while pressing patch to skin for secure adhesion.

Warnings

Use only as directed

do not bandage tightly or use with a healing pad

avoid contact with the eyes and mucous membranes

do not apply to wounds or damaged skin

Dosage & Administration

For external use only

* Please review the disclaimer below.

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