NDC 0295-9008 Cvs Maximum Strength Anti-fungal Pen 25%

Undecylenic Acid

NDC Product Code 0295-9008

NDC Code: 0295-9008

Proprietary Name: Cvs Maximum Strength Anti-fungal Pen 25% Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Undecylenic Acid Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 0295 - Denison Pharmaceuticals, Llc
    • 0295-9008 - Cvs Maximum Strength Anti-fungal Pen 25%

NDC 0295-9008-16

Package Description: 3 mL in 1 TUBE, WITH APPLICATOR

NDC Product Information

Cvs Maximum Strength Anti-fungal Pen 25% with NDC 0295-9008 is a a human over the counter drug product labeled by Denison Pharmaceuticals, Llc. The generic name of Cvs Maximum Strength Anti-fungal Pen 25% is undecylenic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Denison Pharmaceuticals, Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.


Cvs Maximum Strength Anti-fungal Pen 25% 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.

  • UNDECYLENIC ACID 25 mg/100mL

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.

  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)

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: Denison Pharmaceuticals, Llc
Labeler Code: 0295
FDA Application Number: part333C 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 01-09-2019 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: 12-31-2020 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.

Cvs Maximum Strength Anti-fungal Pen 25% Product Label Images

Cvs Maximum Strength Anti-fungal Pen 25% 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 ingredientUndecylenic acid 25%

Otc - Purpose

PurposeAnti-fungal

Indications & Usage

  • UsesFor the cure of most ringworm (tinea capitis)athlete's foot (tinea pedis)For the relief of: itchingscalingcracking burning rednesssorenessirritation and discomforts which may accompany these conditions

Warnings

  • WarningsFor external use only Ask a doctor before use on children under 2 years of ageWhen using this product avoid contact with the eyesStop use and ask a doctor if irritation occurs there is no improvement within 4 weeks

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

  • Directionsread all warnings and directionsuse only as directedclean the affected area with soap and water and dry thoroughlyremove cap from pen, with brush pointing downward, until product dispensesapply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctorfor athlete's foot, pay special attention to spaces between the toes; well-fitting, ventilated shoes, and change shoes and socks at least once dailyfor athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.supervise children in the use of this productthis product is not effective on the scalp or nails

Other Safety Information

  • Other informationStore at 15
  • O - 30
  • OC (59
  • O - 86
  • OF)
  • Keep cap on pen when not in use

Inactive Ingredient

Inactive ingredientIsopropyl Palmitate

* Please review the disclaimer below.

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