NDC 73344-103 Rocksauce Fire

Methyl Salicylate, Menthol And Capsaicin

NDC Product Code 73344-103

NDC 73344-103-01

Package Description: 1 BOTTLE in 1 PACKAGE > 88.7 mL in 1 BOTTLE

NDC 73344-103-02

Package Description: 1 BOTTLE in 1 PACKAGE > 355 mL in 1 BOTTLE

NDC Product Information

Rocksauce Fire with NDC 73344-103 is a a human over the counter drug product labeled by Ningbo Sante Ying Medicaland Healthdevelopment Co.,ltd. The generic name of Rocksauce Fire is methyl salicylate, menthol and capsaicin. The product's dosage form is cream and is administered via topical form.

Labeler Name: Ningbo Sante Ying Medicaland Healthdevelopment Co.,ltd

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 Fire 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.

  • METHYL SALICYLATE 20 mg/100mL
  • MENTHOL 10 mg/100mL
  • CAPSAICIN .2 mg/100mL

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 (UNII: O80TY208ZW)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • WATER (UNII: 059QF0KO0R)

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: Ningbo Sante Ying Medicaland Healthdevelopment Co.,ltd
Labeler Code: 73344
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: 09-29-2019 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.

Rocksauce Fire Product Label Images

Rocksauce Fire 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

Methyl Salicylate 20%Menthol USP 10%Capsaicin 0.002%

Purpose

Topical Analgesic

Uses:

Provides soothing Cold to sore muscles and joints

Warnings:

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

Keep Out Of Reach Of Children.

If accidental ingestion, get medical help or call a Poison Control Center right away.

Directions:

Apply liberally to area of pain and massage unti lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68° to77°F (20°to 25°C).

When Using This Product

Do not heat, microwave, and to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrans, take by mouth or place in nostrill, apply to wounds or damaged skin. Do not use otherwise than as directed

Consult A Doctor And Discontinus Use.

If irritation occurs, ask a health professional before use if pregnant or brastfeeding. before using if you have sensitive skin.

Inactive Ingredients:

Water, Aminomethyl Propanol, Aloe Barbadensis (Aloe Vera) Leaf Extract, Arnica Montana Extract, Carbomer, Cetearl Alcohol, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Phenoxyethanol, Propylene Glycol, Tocopheryl Acetate

* Please review the disclaimer below.