NDC 72587-110 Cycle

Menthol

NDC Product Code 72587-110

NDC 72587-110-22

Package Description: 4 PATCH in 1 POUCH > .05 g in 1 PATCH

NDC Product Information

Cycle with NDC 72587-110 is a a human over the counter drug product labeled by Bdk Group, Llc. The generic name of Cycle is menthol. The product's dosage form is patch and is administered via topical form.

Labeler Name: Bdk Group, Llc

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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.

Cycle 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 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.

  • BLACK COHOSH (UNII: K73E24S6X9)
  • VINYL ACETATE (UNII: L9MK238N77)

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: Bdk Group, Llc
Labeler Code: 72587
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: 09-01-2020 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.

Cycle 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 (5%)

Otc - Purpose

PurposeTopical Analgesic

Indications & Usage

  • Uses For the temporary relief of minor aches and pains of muscles and joints associated with
  • Crampssimple backache

Warnings

Warnings For external use only

Otc - When Using

  • When using this productuse only as directed

Otc - Do Not Use

  • Do not usewith other topical productson open wounds or damaged skin

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsensredness is presentirritation developsdo not apply local heat (such as heating pads) to the area of useyou experience signs of skin injury, such as pain, swelling or blistering where the product was applied

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. In case of ingestion, seek professional assistance and contact poison control immediately.

Dosage & Administration

  • Directions adults and children over 12 yearsremove backing from patchapply patch to abdomenwear patch for up to 12 hoursChildren 12 years or younger: ask a doctor

Storage And Handling

Other InformationReseal the envelope by squeezing seal together.Store in a cool, dry place.

Inactive Ingredient

Inactive Ingredients 2-propenoic acid, 2-methyl-, methyl ester, polymer with ethenyl acetate and 2-ethylhexyl 2-propenoate, black cohosh (cimicifuga racemosa)

Otc - Questions

Questions or Comments: (310) 909-8407
Distributed by:
LA MEND, INC.Cleveland, TN 37312thegoodpatch.com

* Please review the disclaimer below.