NDC 24909-106 Terrasil Anti-fungal Treatment Max

Clotrimazole

NDC Product Code 24909-106

NDC 24909-106-14

Package Description: 14 g in 1 JAR

NDC 24909-106-15

Package Description: 14 g in 1 TUBE

NDC 24909-106-20

Package Description: 200 g in 1 JAR

NDC 24909-106-44

Package Description: 44 g in 1 JAR

NDC 24909-106-50

Package Description: 50 g in 1 TUBE

NDC Product Information

Terrasil Anti-fungal Treatment Max with NDC 24909-106 is a a human over the counter drug product labeled by Aidance Skincare & Topical Solutions, Llc. The generic name of Terrasil Anti-fungal Treatment Max is clotrimazole. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Aidance Skincare & Topical Solutions, Llc

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Terrasil Anti-fungal Treatment Max 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.

  • CLOTRIMAZOLE 1 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.

  • BENTONITE (UNII: A3N5ZCN45C)
  • JOJOBA OIL (UNII: 724GKU717M)
  • MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • SILVER OXIDE (UNII: 897WUN6G6T)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • ZINC OXIDE (UNII: SOI2LOH54Z)

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: Aidance Skincare & Topical Solutions, Llc
Labeler Code: 24909
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: 09-07-2012 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: 12-31-2020 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’.

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Information for Patients

Clotrimazole

Clotrimazole is pronounced as (kloe trim' a zole)

Why is clotrimazole medication prescribed?
Clotrimazole is used to treat yeast infections of the vagina, mouth, and skin such as athlete's foot, jock itch, and body ringworm. It can also be used to prevent oral th...
[Read More]

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Terrasil Anti-fungal Treatment Max Product Label Images

Terrasil Anti-fungal Treatment Max 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

Clotrimazole 1%

Purpose

Antifungal

Uses

  • Cures most fungal skin infections, including ringworm and tinea. For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness and chafing associated with fungal skin infections.

Warnings

For external use only. Do not use on children under two years of age unless directed by a physician. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a physician.

Keep Out Of Reach Of Children.

If swallowed, call poison control or seek medical help.

Directions

Wash and dry affected skin. Apply a thin layer of Terrasil over the affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. Store at room temperature.

Inactive Ingredients

Bentonite, Cera Alba (Organic Beeswax), Magnesium Oxide, Peppermint Oil, Silver Oxide, Simmondsia Chinensis (Jojoba) Seed Oil, Tea Tree Oil, Zinc Oxide

* Please review the disclaimer below.