NDC 0536-1332 Rugby Menthol Hot Cold Patch

Menthol

NDC Product Code 0536-1332

NDC CODE: 0536-1332

Proprietary Name: Rugby Menthol Hot Cold 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: Menthol 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.

Product Characteristics

Shape: RECTANGLE (C48347)

NDC Code Structure

  • 0536 - Rugby Laboratories

NDC 0536-1332-15

Package Description: 5 PATCH in 1 CARTON > 9 g in 1 PATCH

NDC Product Information

Rugby Menthol Hot Cold Patch with NDC 0536-1332 is a a human over the counter drug product labeled by Rugby Laboratories. The generic name of Rugby Menthol Hot Cold Patch is menthol. The product's dosage form is patch and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 420222.

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.

Rugby Menthol Hot Cold 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.

  • DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • KAOLIN (UNII: 24H4NWX5CO)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • TARTARIC ACID (UNII: W4888I119H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)
  • CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)

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: Rugby Laboratories
Labeler Code: 0536
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: 07-01-2021 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.

Rugby Menthol Hot Cold Patch Product Label Images

Rugby Menthol Hot Cold 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

Menthol 5% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Analgesic

Purpose

Topical analgesic

Warnings

For external use only

When Using This Product

■ use only as directed■ Rare cases of serious burns have been reported with products of this type■ don't bandage tightly or use with a heating pad■ Avoid contact with the eyes and mucous membranes■Don't apply to wounds or damaged skin■ do not use at the same time as other topical analgesics

Stop Use And Consult A Doctor

■ condition worsens■ redness is present■ irritation develops■ 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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Keep Out Of Reach Of Children

Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.

Directions

  • Directions Adults and children 12 years of age and over:carefully remove backing from patchapply sticky side of patch to affected areawear one patch up to 8 hoursrepeat as necessary, but no more than 3 times dailydiscard patch after single usereseal pouch after opening.Children under 12 years of age: consult a physician.

Other Safety Information

Store at room temperature, not to exceed 86F (30C)

Inactive Ingredients

CMC, dihydroxyaluminum aminoacetate, Glycerin, Kaolin, Methylparaben, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Questions

Call 1-800-645-2158

Indications & Usage

Targeted, long-lasting pain relief

* Please review the disclaimer below.