NDC 36800-252 Menthol

Maximum Strength Medicated Foot Powder Talc Free

NDC Product Code 36800-252

NDC Product Information

Menthol with NDC 36800-252 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Menthol is maximum strength medicated foot powder talc free. The product's dosage form is powder and is administered via topical form.

Labeler Name: Topco Associates Llc

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Menthol Active Ingredient(s)

Additional informationCallout TooltipWhat 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 2.8 g/283g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • BENZETHONIUM CHLORIDE (UNII: PH41D05744)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)
  • TRICALCIUM PHOSPHATE (UNII: K4C08XP666)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Topco Associates Llc
Labeler Code: 36800
FDA Application Number: part348 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-10-2019 Additional informationCallout TooltipWhat 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: 12-31-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Menthol Product Label Images

Menthol 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 1.0%

Purpose

External analgesic

Use

For the temporary relief of pain and itching associated with minor skin irritation

Warnings

For external use only.

When Using This Product

  • Avoid contact with eyes

Stop And Consult A Doctor If

  • Conditions worsenssymptoms persists for more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 2 years of age and older, apply to affected area not more than 3 to 4 times dailychildren under 2 years of age, consult a doctorwash and dry feet thoroughlysprinkle powder liberally on feet, between toes and on bottoms of feet

Inactive Ingredients

Benzathonium Chloride, eucalyptus oil, peppermint oil, sodium bicarbonate, tricalcium phosphate, zea mays (corn) starch

Questions?

Call - 1-888-423-0139

* Please review the disclaimer below.

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