NDC 72667-013 Bl3 Mineral Ice Gel

Menthol

NDC Product Code 72667-013

NDC Product Information

Bl3 Mineral Ice Gel with NDC 72667-013 is a a human over the counter drug product labeled by Inspec Solutions, Llc.. The generic name of Bl3 Mineral Ice Gel is menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Inspec Solutions, Llc.

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.

Bl3 Mineral Ice Gel 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 2 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.

  • THYMOL (UNII: 3J50XA376E)
  • CARBOMER 1342 (UNII: 809Y72KV36)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • TETRAETHYLAMMONIUM HYDROXIDE HEXAHYDRATE (UNII: 2GBD78DRH6)
  • CUPRIC SULFATE ANHYDROUS (UNII: KUW2Q3U1VV)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)

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: Inspec Solutions, Llc.
Labeler Code: 72667
FDA Application Number: part346 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 06-12-2019 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.

Bl3 Mineral Ice Gel Product Label Images

Bl3 Mineral Ice Gel 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

Otc - Active Ingredient

Active IngredientMenthol 2%

Otc - Purpose

Menthol 2% .........................Analgesic

Indications & Usage

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

Warnings

WarningsFor external use only• sue only as directed• avoid contact with eyes• do not bandage tightly• do not apply to wounds or damaged skin•​ do not use with heating pad

Otc - Stop Use

Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Direction• For adult & children 2 years of age and older• Cleans ad dry skin• Apply to affected area not more than 3 to 4 times daily• may be used with wet or dry bandages in conjunction with ice packs• children under 2 years of age, consult a doctor

Inactive Ingredient

Inactive Ingredients Ammonium Hydroxide, Carbomer, Cupric Sulfate, FD&C Blue No. 1, Isopropyl Alcohol, Magnesium Sulfate, Sodium Hydroxide, Thymol, Water.

* Please review the disclaimer below.

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