NDC 72886-3021 Blue Analgesic Gel

Menthol

NDC Product Code 72886-3021

NDC Product Information

Blue Analgesic Gel with NDC 72886-3021 is a a human over the counter drug product labeled by Crystal Curam. The generic name of Blue Analgesic Gel is menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Crystal Curam

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.

Blue Analgesic 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 1.25 g/100g
  • CAMPHOR (SYNTHETIC) .5 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.

  • METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)

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: Crystal Curam
Labeler Code: 72886
FDA Application Number: part341 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: 04-08-2019 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.

Blue Analgesic Gel Product Label Images

Blue Analgesic 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

Active Ingredients

Menthol 1.25 %Camphor 0.5%

Purpose

Topical Analgesic

Uses:

  • For temporary relief of minor aches and pains in muscles and joints associated with:simple backaches,strainssprainssports injuriesarthritisbruises

Warnings

  • FOR EXTERNAL USE ONLYDo not use:with other topical pain relieverswith heating pads or heating devices

When Using This Product

  • Do not use in or near eyesdo not apply to wounds or damaged skindo not bandage tightly

Stop Use And Ask A Doctor If

  • Condition worsenssymptoms last more than 7 days or clear up and occur again within a few daysredness or irritation develops

If Pregnant Or Breastfeeding

Ask a health professional before use

Keep Out Of Reach Of Children

If swallowed get Medical Help or contact a Poison Control Center right away

Directions

  • Clean affected area before applying productadults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily

Inactive Ingredients

Carbomer, FD&C Blue No.1, Methyl Paraben Sodium, Methyl Salicylate, Propylene Glycol, Propyl Paraben Sodium, Sodium hydroxide, Water

* Please review the disclaimer below.

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