NDC 64479-200 Painpatrol Professional Pain Relief

Menthol, Unspecified Form

NDC Product Code 64479-200

NDC Code: 64479-200

Proprietary Name: Painpatrol Professional Pain Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Menthol, Unspecified Form What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 64479 - Smartscience Laboratories, Inc.
    • 64479-200 - Painpatrol Professional Pain Relief

NDC 64479-200-10

Package Description: 88 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Painpatrol Professional Pain Relief with NDC 64479-200 is a a human over the counter drug product labeled by Smartscience Laboratories, Inc.. The generic name of Painpatrol Professional Pain Relief is menthol, unspecified form. The product's dosage form is gel and is administered via topical form.

Labeler Name: Smartscience Laboratories, Inc.

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.


Painpatrol Professional 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, UNSPECIFIED FORM 85 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • CHONDROITIN SULFATE (SHARK) (UNII: 2ZAJ1K50XH)
  • GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • 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: Smartscience Laboratories, Inc.
Labeler Code: 64479
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: 03-10-2019 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.

Painpatrol Professional Pain Relief Product Label Images

Painpatrol Professional 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

Other

Drug Facts

Manufactured by: SmartScience Laboratories, Inc 13760 Reptron Blvd., Tampa, FL 33626

Active Ingredient

Natural Menthol, USP (8.5%)

Purpose

Topical Analgesic

Uses

  • Temporarily relieves foot, ankle and leg pain associated with:arthritismuscle achesmuscle strainsmuscle sprainsjoint pain

Warnings

For external use only: Flammable: Keep away from excessive heat or open flame.

Otc - Ask Doctor

  • Ask a doctor before use is you have sensitive skin or if you are taking any blood thinners,

When Using This Product

  • Do not use on wounds or irritated skinDo not bandage tightly or usewith a heating padWash hands after use with cool water

Otc - Pregnancy Or Breast Feeding

  • If pregnant or breast feeding, ask a health professional before use

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. If accidentally swallowed,contact a doctor or poison control center immediately

Otc - Stop Use

  • Stop use and ask a doctor if condition worsens or if pain persists for more than 7 days, or clears up, then reoccurs within a few days.

Directions

  • Use only as directedDo not use on children under 12 years of age.Roll onto affected area no more than four times daily. Shake well before each use.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arnica Montana Extract, Boswellia Serrata Extract, Camphor, Carbomer, Chondroitin Sulfate, Glucosamine Sulfate, Glycerin, Ilex Paraguarensis Extract, Isopropyl Alcohol, Methyl Paraben, Methylsulfonylmethane, Peppermint Oil, Polysorbate 20, Propylene Glycol, Triethanolamine, Purified Water

Storage And Handling

Store in a cool dry place with the cap tightly closed. Note: Because this product contains natural ingredients, color may vary.

* Please review the disclaimer below.

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