NDC 72594-5000 Fourpainrx

Lidocaine Hcl, Methyl Salicylate, Menthol, Capsaicin

NDC Product Code 72594-5000

NDC 72594-5000-1

Package Description: 121 g in 1 TUBE

NDC Product Information

Fourpainrx with NDC 72594-5000 is a a human over the counter drug product labeled by Neptune Products Llc. The generic name of Fourpainrx is lidocaine hcl, methyl salicylate, menthol, capsaicin. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Neptune Products Llc

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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.

Fourpainrx 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.

  • CAPSAICIN .04 g/121g
  • METHYL SALICYLATE 33.28 g/121g
  • MENTHOL 12.1 g/121g
  • LIDOCAINE HYDROCHLORIDE 4.84 g/121g

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.

  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CHAMOMILE (UNII: FGL3685T2X)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ALLANTOIN (UNII: 344S277G0Z)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • INULIN (UNII: JOS53KRJ01)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • WATER (UNII: 059QF0KO0R)
  • TROLAMINE (UNII: 9O3K93S3TK)

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.
  • 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: Neptune Products Llc
Labeler Code: 72594
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: 10-26-2020 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: 12-31-2021 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.

Fourpainrx 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

Lidocaine HCL 4%Methyl Salicylate 27.5%Menthol 10%Capsaicin 0.0325%

Otc - Purpose

Topical AnestheticTopical NSAIDTopical AnalgesicCounterirritant

Indications & Usage

  • Temporarily relieves minor aches and muscles pains associated with:arthritissimple back painstrainsmuscle soreness

Warnings

For external use only

Do Not Use

  • On open wounds, cuts, damaged or infected skinwith bandage or a heating padif condition worsens or symptoms persists for more than 7 daysexcessive skin irritation occurs

Ask A Doctor Before Use If

  • You are allergic to any ingredients, PABA, aspirin products or sulfa

Otc - When Using

  • Avoid contact with eyes, genitals, and other mucus membranes. If eye contact occurs, rinse thoroughly with water.

If Pregnant Or Breast Feeding

Ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away. Package not child resistant.

Storage And Handling

Store at at 20ºC - 25ºC (68ºF - 77ºF)

Directions

  • Adults 18 years and children 12 years and older:apply product directly to affected areaproduct may be used as necessary, but should not be used more than four times per day.wash hands immediately afterwardsChildren 12 years or younger: ask a doctor

Inactive Ingredient

Allantoin, Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetyl Alcohol, Chamomilla Recutita Matricaria Flower Extract, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Inulin Lauryl Carbamate, PEG-100 Stearate, Phenoxyethanol, Stearic Acid, Triethanolamine, Water.

* Please review the disclaimer below.