NDC 55319-055 Undecylenic Acid

  1. Labeler Index
  2. Family Dollar Services Inc.
  3. NDC: 55319-055 Undecylenic Acid

NDC Product Code 55319-055

NDC CODE: 55319-055

Proprietary Name: Undecylenic Acid What 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
  • This product is used as antifungal

NDC Code Structure

NDC 55319-055-17

Package Description: 1.7 mL in 1 APPLICATOR

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Undecylenic Acid with NDC 55319-055 is product labeled by Family Dollar Services Inc.. The product's dosage form is and is administered via form.

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)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Family Dollar Services Inc.
Labeler Code: 55319
Start Marketing Date: 12-15-2017 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

* Please review the disclaimer below.

Undecylenic Acid Product Label Images

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 the cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm)For relief of:itchingburningrednessirritationscalingdiscomfort which may accompany these conditionssoreness

Warnings

For external use only.

If Pregnant Or Breastfeeding

Consult a healthcare professional before use.

Do Not Use

On children 2 years of age unless directed by a doctor.

When Using This Product

Avoid contact with eyes.

Use Only As Directed

By a 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 Children.

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

Directions

Read all warning and directions. Use only as directed.clean the affected area and dry thoroughlytwist pen base with 3 clicks to saturate brushapply a thin layer of the product over the affected area twice daily (morning and night) or as directed by the doctorthe brush applicator allows for easy application under nails and surrounding cuticle areasupervise children in the use of this productfor athlete's foot: pay special attention to spaces between the toeswear 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.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 temperature.keep tightly closed when not in use

Inactive Ingredient

Isopropyl palmitate

Questions?

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* Please review the disclaimer below.