NDC 65923-139 Soundbody Clotrimazole Antifungal

NDC Product Code 65923-139

NDC CODE: 65923-139

Proprietary Name: Soundbody Clotrimazole Antifungal 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.

NDC Code Structure

  • 65923 - United Exchange Corp.
    • 65923-139 - Soundbody Clotrimazole Antifungal

NDC 65923-139-28

Package Description: 1 TUBE in 1 BOX > 28 g in 1 TUBE

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

NDC Product Information

Soundbody Clotrimazole Antifungal with NDC 65923-139 is a product labeled by United Exchange Corp.. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 309367.

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.

  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETYL ESTERS WAX (UNII: D072FFP9GU)
  • MAGNESIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: H3992158BT)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Product Labeler Information

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

Labeler Name: United Exchange Corp.
Labeler Code: 65923
Start Marketing Date: 02-26-2014 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: 12-31-2018 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".

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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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Soundbody Clotrimazole Antifungal Product Label Images

Soundbody Clotrimazole 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

Otc - Active Ingredient

Active ingredients                          PurposeClotrimazole 1%.......................... Antifungal

Otc - Purpose

  • UsesCures most athletes foot, jock itch, and ringwormrelieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

WarningsFor external use onlyDo not use on children under 2 years of age unless directed by a doctor.

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 right away.

Indications & Usage

  • Directionswash 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 spaces between the toes, wear well-fitting, ventilated shoes, and change shoes and socks at least once a dayfor athlete's foot and ringwom use daily for 4 weeks; for jock itch; use daily for 2 weeksthis product is not effective on the scalp or nails

Storage And Handling

  • Other informationstore between 20° to 25°C (68° to 77°F)Lot No. & Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients2-octyldodecanol, benzyl alcohol, cetostearyl alcohol, cetyl esters, monobasic sodium phosphate dihydrate, polysorbate 60, propylene glycol, purified water, sorbitan stearate

Dosage & Administration

DISTRIBUTED BY:UNITED EXCHANGE CORP.17211 VALLEY VIEW AVE.CERRITOS, CA 90703 USA

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