NDC 76973-071 Emoninail Antifungal

Undecylenic Acid

NDC Product Code 76973-071

NDC 76973-071-08

Package Description: 24 mL in 1 BOTTLE, DROPPER

NDC Product Information

Emoninail Antifungal with NDC 76973-071 is a a human over the counter drug product labeled by Gg Healthworks Inc.. The generic name of Emoninail Antifungal is undecylenic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Gg Healthworks Inc.

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.

Emoninail Antifungal 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.

  • UNDECYLENIC ACID 100 mg/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • LAURETH-7 (UNII: Z95S6G8201)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

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: Gg Healthworks Inc.
Labeler Code: 76973
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: 05-01-2020 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.

Emoninail Antifungal Product Label Images

Emoninail Antifungal 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 10.00%

Purpose

Topical Antifungal

Uses

Proven clinically effective in the treatment of most fungal infections related/associated to tinea pedis (athlete's foot) or tinea corporis (ringworm).

Warnings

  • For external use only

Do Not Use

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

Stop Use And Ask A Doctor If,

  • If irritation occurs or if there is no improvement within 4 weeks.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

When Using This Product,

Avoid contact with eyes.

Directions

  • Wash the affected area and dry thoroughly.Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.Supervise children in the use of this product.For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes andsocks at least once daily.For 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

  • Protect the product in this container from excessive heat and direct sun.

Store between 20° to 30°C (68° to 86°F)

Inactive Ingredients

Aqua (Deionized Water), SD-Alcohol 40B, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Cetyl Alcohol, Polysorbate-20, Polycrylamide, C13-C14 Isoparaffin, Laureth-7, Glycerin, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Ethylhexyglycerin.

* Please review the disclaimer below.