NDC 73344-101 Rocksauce Ice

Menthol

NDC Product Code 73344-101

NDC 73344-101-01

Package Description: 2.5 g in 1 JAR

NDC Product Information

Rocksauce Ice with NDC 73344-101 is a a human over the counter drug product labeled by Ningbo Sante Ying Medicaland Healthdevelopment Co.,ltd. The generic name of Rocksauce Ice is menthol. The product's dosage form is gel and is administered via topical form.

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

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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 Ice 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 6 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.

  • WATER (UNII: 059QF0KO0R)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ARCTIUM LAPPA ROOT OIL (UNII: 55DGS3F5YG)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • MELISSA OFFICINALIS LEAF OIL (UNII: PTP6R7263M)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

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 Ice Product Label Images

Rocksauce Ice 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

Menthol 6.0%

Purpose

Topical Analgesic

Uses

Provides soothing cold to sore muscles

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 membane, take by mouth or place in nostrils, apply to wounds or damaged skin.Do not use otherwise than as directed.

Consult A Doctor And Discontinue Use

If irritation occurs.

Keep Out Of Reach Of Children.

In case of accidental ingestion, get medical help or call a Poison Control Center right away.

Directions

Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. See important warnings under "When using this product". Not for childern 5 years or younger. Store at 68° to 77°F (20° to 25°C).

Inactive Ingredients

Water, Isopropyl Alcohol, Glycerin, Aloe Barbadensis Leaf Extract, Calendula Officinalis Extract, Arctium Lappa (Burdock) Root Extract, Ilex Paraguariensis Leaf Extract, Arnica MOntana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis (Green Tea) Leaf Extract, Melissa Officinalis (Lemon Balm) Leaf Extract, Camphor, Isopropyl Myristate, Carbomer, Triethanolamine, Silica, Tocopheryl (Vitamin E) Acetate

* Please review the disclaimer below.