NDC 72909-014 Ireliev Roll On Cool Pain Relief

Menthol

NDC Product Code 72909-014

NDC 72909-014-01

Package Description: 88 mL in 1 BOTTLE

NDC Product Information

Ireliev Roll On Cool Pain Relief with NDC 72909-014 is a a human over the counter drug product labeled by Excel Health, Inc. The generic name of Ireliev Roll On Cool Pain Relief is menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Excel Health, 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.

Ireliev Roll On Cool 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 60 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)
  • WATER (UNII: 059QF0KO0R)
  • ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • MELISSA OFFICINALIS (UNII: YF70189L0N)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: Excel Health, Inc
Labeler Code: 72909
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: 02-20-2019 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.

Ireliev Roll On Cool Pain Relief Product Label Images

Ireliev Roll On Cool 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

Menthol 6%

Indications:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises, and strains.

Warnings

  • For external use onlyAvoid contact with eyesIf symptoms persist for more than seven days, discontinue use and consult physician.

Keep Out Of Reach Of Children

If swallowed, consult physician

Do Not Apply

  • To wounds or damaged skinDo not bandage tightly

If Pregnant Or Breast Feeding

Contact physician prior to use

Directions

  • Adults and children two-years of age or older: Apply to affected area not more than three to four times dailChildren under two-years of age: consult a physician

Other Information

Store at room temperature

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arctium Lappa (Burdock) Root Extract, Arnica Montana Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis (Yerba Mate’) Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Extract, Phenoxyethanol, Polysorbate- 20,  Tocopheryl Acetate (Vitamin E), Triethanolamine

* Please review the disclaimer below.

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