NDC 81765-184 Fors Pain Relief

Menthol, Capsaicin

NDC Product Code 81765-184

NDC 81765-184-01

Package Description: 1 JAR in 1 BOX > 60 mL in 1 JAR

NDC Product Information

Fors Pain Relief with NDC 81765-184 is a a human over the counter drug product labeled by Fors Llc. The generic name of Fors Pain Relief is menthol, capsaicin. The product's dosage form is cream and is administered via topical form.

Labeler Name: Fors 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.

Fors 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.

  • MENTHOL 40 mg/mL
  • CAPSAICIN .35 mg/mL

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.

  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • ALLANTOIN (UNII: 344S277G0Z)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CANNABIDIOL (UNII: 19GBJ60SN5)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • SQUALANE (UNII: GW89575KF9)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: Fors Llc
Labeler Code: 81765
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: 04-05-2021 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.

Fors Pain Relief Product Label Images

Fors 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

Active Ingredients

Menthol 4.00%Capsaicin 0.035%

Purpose

Topical Analgesic

Uses:

  • For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis strains, bruises, and sprains.

Warnings:

For external use only

Do Not Use

  • On damaged or broken skin.

When Using This Product

  • Keep out of eyes. Rinse with water to remove. Do not bandage tightly.

Stop Use And Ask A Doctor If

  • Rash or irritation develops and lasts. Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poision Control Center right away.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Directions:

  • Adults and children 2 years of age and older: Apply to affected area not ore than 3 to 4 times daily.Children under 2 years of age: consult doctor.

Other Information:

Store at 20-25 C (68-77 F) and protect from moisture.

Inactive Ingredients:

Acrylates/C10-30 Alky Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf(Aloe Vera Gel) Juice, Aqua (Deionized Water), Amica Montana Flower Extract, Boswellia Serrata Extract, Butylene Glycol, *Cannabidiol (CBD), Caprylic/Capric Triglyceride, Celeareth-20, Cetyl Alcohol, Ethylhexyglycerin, Eucalyptus Globulus Oil, Glycerin, Clyceryl Stearate,Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurale Copolymer, Ilex


Paraguayensis (Yerba Mate) Extract, Methylsulfonylmethane (MSM), Mineral Oil, Phenoxyethanol, Polysorbate-20, Polysorbate-60, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Squalane Stearic Acid, Triethanolamine, Tocopheryl Acetate (Vitamin E).

Questions?

1-800-210-7924

* Please review the disclaimer below.