NDC 81683-013 Rocksauce Fiery Hot Pain Relief

Methyl Salicylate, Menthol, Capsaicin

NDC Product Code 81683-013

NDC 81683-013-01

Package Description: 88.5 mL in 1 BOTTLE

NDC Product Information

Rocksauce Fiery Hot Pain Relief with NDC 81683-013 is a a human over the counter drug product labeled by Implus Footcare, Llc. The generic name of Rocksauce Fiery Hot Pain Relief is methyl salicylate, menthol, capsaicin. The product's dosage form is cream and is administered via topical form.

Labeler Name: Implus Footcare, 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.

Rocksauce Fiery Hot 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 9.02 g/88.5mL
  • CAPSAICIN .0018 g/88.5mL
  • METHYL SALICYLATE 18 g/88.5mL

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.

  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • WATER (UNII: 059QF0KO0R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

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: Implus Footcare, Llc
Labeler Code: 81683
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: 03-18-2021 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.

Rocksauce Fiery Hot Pain Relief Product Label Images

Rocksauce Fiery Hot 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 Ingredient

Methyl Salicylate 20%Menthol 10%Capsaicin0.002%

Purpose

Topical Analgesic

Uses:

Provides soothing heat to sore muscles and joints.

Warnings:

For external use only. Avoid contact with eyes, mucous membrane or broken skin.

When Using This Product, Do Not:

Heat, microwave, add to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrane, take by mouth or place in nostrils, apply to wounds or damaged skin.

Otc - Do Not Use

Do not use otherwise than as directed.

Otc - Ask Doctor

Consult a doctor and discontinue use if irritation occurs.Ask a health professional before use if pregnant or breastfeeding.Ask a doctor before using if you have sensitive skin.

Keep Out Of Reach Of Children:

In case of accidental ingestion, get medical help or call Poison Control Center right away. Not for children 5 years or younger.

Directions:

Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68° to 77 ℉(20° to 25℃).

Inactive Ingredients:

Aminomethyl Propanol, Aloe Barbadensis(Aloe Vera)Leaf Juice, Arnica Montana Flower Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetearyl Alcohol, Ethylhexylglycerin, Maltodextrin, Phenoxyethanol, Propylene Glycol, Potassium Cetyl Phosphate, Tocopheryl Acetate, Water

* Please review the disclaimer below.