NDC 66902-195 Evel Knievels Natural Choice Pain Relief

Menthol, Unspecified Form

NDC Product Code 66902-195

NDC CODE: 66902-195

Proprietary Name: Evel Knievels Natural Choice 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.

NDC Code Structure

  • 66902 - Natural Essentials, Inc.
    • 66902-195 - Evel Knievels Natural Choice Pain Relief

NDC 66902-195-03

Package Description: 85 g in 1 BOTTLE

NDC Product Information

Evel Knievels Natural Choice Pain Relief with NDC 66902-195 is a a human over the counter drug product labeled by Natural Essentials, Inc.. The generic name of Evel Knievels Natural Choice Pain Relief is menthol, unspecified form. The product's dosage form is gel and is administered via topical form.

Labeler Name: Natural Essentials, 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.

Evel Knievels Natural Choice 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 100 mg/g

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 COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • 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.
  • 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: Natural Essentials, Inc.
Labeler Code: 66902
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: 05-29-2020 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: 12-31-2021 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.

Evel Knievels Natural Choice Pain Relief Product Label Images

Evel Knievels Natural Choice 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

Natural Menthol USP 10.0%

Purpose

Cooling Pain Relief

Uses

  • Temporary relief of minor aches and pains of muscles and joints associated with:
  • Simple backache
  • Arthritis
  • Strains
  • Sprains

Warnings

  • For external use onlyFlammable
  • Keep away from excessive heat or open flame

Do Not Use

  • With heating pad or device
  • With ointments, creams, sprays or liniments
  • On wounds, damaged skin or irritated skin

Ask A Doctor Before Use If You

  • Have sensitive skin
  • Are pregnant or breastfeeding

When Using This Product

  • Avoid contact with eyes or mucous membranes
  • Do not bandage tightly

Stop Use And Ask A Doctor If

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up then reoccur again within a few days
  • Irritation develops

Keep Out Of Reach Of Children.

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

Adults/Children 2 Years And Older:

  • Roll on the affected area not more than 3 to 4 times daily
  • Shake well before use

Children Under 2 Years Old:

Consult a physician.

Other Information

  • Replace a cap after use
  • Store in a cool, dry place

Inactive Ingredients

Acrylate Crosspolymer, Camphor, Cannabis Sativa Seed Oil, Ethylhexylglycerin, FD&C Blue#1, FD&C Yellow#5, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylsulfonylmethane USP, Organic Aloe Barbadensis Leaf Juice, Organic Arnica Montana Flower Extract, Phenoxyethanol, Silicone Dioxide, Sodium Chloride, Tocopheryl Acetate, Triethanolamine, Water.

* Please review the disclaimer below.