Soundbody Clotrimazole Antifungal
FDA Label NDC 65923-139

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Soundbody Clotrimazole Antifungal (NDC 65923-139). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients                          Purpose

Clotrimazole 1%.......................... Antifungal

Otc - Purpose

Uses

  • Cures most athletes foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

Warnings

For external use only

Do not use on children under 2 years of age unless directed by a doctor.

Otc - Stop Use

Stop use and ask a doctor if

  • irritation occurs
  • there 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

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • 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 and socks at least once a day
  • for athlete's foot and ringwom use daily for 4 weeks; for jock itch; use daily for 2 weeks
  • this product is not effective on the scalp or nails

Storage And Handling

Other information

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

Inactive Ingredient

Inactive ingredients

2-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

Package Label.Principal Display Panel

Image Description (613.1)

Image Description (613.1)

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