NDC 55910-410 Undecylenic Acid

Anti-fungal Nail Solution

NDC Product Code 55910-410

NDC 55910-410-30

Package Description: 30 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Undecylenic Acid with NDC 55910-410 is a a human over the counter drug product labeled by Dolgencorp, Inc. (dollar General & Rexall). The generic name of Undecylenic Acid is anti-fungal nail solution. The product's dosage form is liquid and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 998329.

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 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.

Undecylenic Acid 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.


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.

  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)

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: Dolgencorp, Inc. (dollar General & Rexall)
Labeler Code: 55910
FDA Application Number: part333C 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: 02-27-2014 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Undecylenic Acid 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

Undecylenic acid 25%w/w

Purpose

Antifungal

Uses

  • For cure of most tinea pedis (athete's foot) and tinea corporis (ringworm)
  • For relief of:discomforts which may accompany these conditonsitchingburningrednessirritationscalingsoreness

Warnings

For external use only.

If Pregnant Or Breastfeeding

Consult a healthcare professional before use.

Do Not Use

On children under 2 years of age unless directed by the doctor.

When Using This Product

Avoid contact with eyes.

Use Only As Directed

By the doctor on persons with highly sensitive skin.

Stop Use And Consult A Doctor If

  • There is no improvement within 4 weeksirritation occurs

Keep Out Of Reach Of Children.

If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

Directions

  • Read all warnings and directions. Use only as directed.clean the affected area and dry thoroughlyapply a thin layer of the product over the affected area twice daily (morning and evening) or as directed by a doctorsupervise children in the use of this productfor athlete's foot: pay special attention to spaces between the toeswear well- fitting, ventilated shoes, and changes shoes and socks atleast once dailyfor athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.this product is not effective on the scalp or nails

Other Information

  • Store at room temperature 150 - 300C (590 - 860F)protect from freezing. If freezing occurs warm to room temperaturekeep tightly closed when not in use

Inactive Ingredient

Isopropyl palmitate

Questions?

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* Please review the disclaimer below.