NDC 72982-1901 Pain Relief Cream Extra Strength

Methyl Salicylate, Menthol, Camphor, Capsaicin Cream

NDC Product Code 72982-1901

NDC Code: 72982-1901

Proprietary Name: Pain Relief Cream Extra Strength 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: Methyl Salicylate, Menthol, Camphor, Capsaicin Cream 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.

NDC Code Structure

  • 72982 - Everyday Medical Llc
    • 72982-1901 - Pain Relief Cream Extra Strength

NDC 72982-1901-1

Package Description: 141 g in 1 CONTAINER

NDC Product Information

Pain Relief Cream Extra Strength with NDC 72982-1901 is a a human over the counter drug product labeled by Everyday Medical Llc. The generic name of Pain Relief Cream Extra Strength is methyl salicylate, menthol, camphor, capsaicin cream. The product's dosage form is cream and is administered via topical form.

Labeler Name: Everyday Medical Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Pain Relief Cream Extra Strength 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 5 g/100g
  • CAMPHOR (NATURAL) 4 g/100g
  • METHYL SALICYLATE 20 g/100g
  • CAPSAICIN .01 g/100g

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.

  • LINSEED OIL (UNII: 84XB4DV00W)
  • WATER (UNII: 059QF0KO0R)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)
  • CURCUMIN (UNII: IT942ZTH98)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • COMFREY (UNII: D05HXK6R3G)
  • EMU OIL (UNII: 344821WD61)
  • CETETH-20 (UNII: I835H2IHHX)

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: Everyday Medical Llc
Labeler Code: 72982
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: 04-08-2019 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.

Pain Relief Cream Extra Strength Product Label Images

Pain Relief Cream Extra Strength 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 PurposeMethyl Salicylate 20% Topical AnalgesicMenthol 5% Topical AnalgesicCamphor 4% Topical AnalgesicCapsaicin.1% Topical Analgesic

Otc - Purpose

Topical analgesic

Indications & Usage

  • Temporarily relieves minor pain associated witharthritissimple backachemuscle strainsbruisessprainscramps

Warnings

  • WarningsFor external use onlyWhen using this product: Use only as directeddo not bandage tightly or use with a heating padavoid contact with eyes and mucous membranesdo not apply to wounds or damaged, broken or irritated skinif severe burning sensation occurs, discontinue use immediatelyStop use and ask a doctor ifcondition worsensredness is presentirritation develops

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away​

Dosage & Administration

  • Use only as directedAdults and children 12 years of age and older apply to affected area not more than 3 to 4 times dailyChildren under the age of 12 years of age consult a doctor

Inactive Ingredient

  • Comfrey extractArnica extractBoswellia serrata extractEmu oilLinseed oilCurcuminVitamin E acetate oilCetomacrogol 1000Ceto steryl alcoholCarbopol 2020Light liquid parafinWhite soft paraffinBHABHTGlyceryl mono stearateSodium meta bisulphateSimethiconePurified water

* Please review the disclaimer below.

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