NDC 72103-527 Athletes Foot

Clotrimazole

NDC Product Code 72103-527

NDC 72103-527-10

Package Description: 1 TUBE in 1 CARTON > 10 g in 1 TUBE

NDC Product Information

Athletes Foot with NDC 72103-527 is a a human over the counter drug product labeled by The Ibn Sina Pharmaceutical Industry Ltd.. The generic name of Athletes Foot is clotrimazole. The product's dosage form is cream and is administered via topical form.

Labeler Name: The Ibn Sina Pharmaceutical Industry Ltd.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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.

Athletes Foot 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.

  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • WATER (UNII: 059QF0KO0R)

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: The Ibn Sina Pharmaceutical Industry Ltd.
Labeler Code: 72103
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: 03-14-2019 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 Topical

Clotrimazole Topical is pronounced as (kloe trim' a zole)

Why is clotrimazole topical medication prescribed?
Topical clotrimazole is used to treat tinea corporis (ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itc...
[Read More]

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Athletes Foot Product Label Images

Athletes Foot 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

Other

Drug Facts

Manufactured by:The
IBN SINA Pharmaceutical Industry Ltd.
Holding # A-80, Ward # 9, Shafipur, KaliakoirGazipur-1751 Bangladeshwww.ibnsinapharma.comProduct of Bangladesh

Otc - Active Ingredient

Active ingredientClotrimazole 1%

Otc - Purpose

PurposeAntifungal

Indications & Usage

  • Usescures most athlete's foot, jock itch and ringwormrelieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

WarningsFor external use only

Otc - Do Not Use

Do not use on children under 2 years of age except under the advice and supervision of a doctor

Otc - When Using

When using this product avoid contact with the eyes

Otc - Stop Use

  • Stop use and ask a doctor ifirritation occursthere is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Dosage & Administration

  • Directionswash the affected area and dry thoroughlyapply a thin layer over affected area twice daily (morning and night)supervise children in the use of this productfor athlete's foot:pay special attention to the spaces between the toeswear well-fitting ventilated shoeschange shoes and socks at least once dailyfor athlete's foot and ringworm: use daily for 4 weeksfor jock itch: use daily for 2 weeksif condition persists longer, consult a doctorthis product is not effective on the scalp or nails

Storage And Handling

  • Other informationstore at 2° - 30° C (36° - 86° F)Lot No. & Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredientscetostearyl alcohol, methylparaben, mineral oil, paraffin, polyoxyl 40 hydrogenated castor oil, polysorbate 80, water

Otc - Questions

Questions?Call
1-833-IBN-SINA (1-833-426-7462)

* Please review the disclaimer below.

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