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SoundBody Tolnaftate Antifungal

Dosage form: cream
Ingredients: TOLNAFTATE 10mg in 1g
Labeler: United Exchange Corp.
NDC Code: 65923-108

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient                             Purpose

Tolnaftate 1%............................... Antifungal

Uses

  • proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • proven effective in the prevention of athlete's foot with daily use
  • for effective relief of itching, burning and cracking

For external use only

When using this product avoid contact with the eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in th euse of this product
  • for athlete's foot, pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change socks at least once a day
  • use daily for 4 weeks; if condition persists longer, ask a doctor
  • to prevent athlete's foot, apply twice daily (morning and/or night)
  • this product is not effect on the scalp or nails

Other information

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

Inactive ingredients

ceteth-20, cetostearyl alcohol, chlorocresol, liquid paraffin, monobasic sodium phosphate dihydrate, propylene glycol, purified water, white petrolatum

DISTRIBUTED BY:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703 USA

SOUNDBODY TOLNAFTATE ANTIFUNGAL 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-108
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETETH-20 
CETOSTEARYL ALCOHOL 
CHLOROCRESOL 
PARAFFIN 
MAGNESIUM PHOSPHATE, MONOBASIC, DIHYDRATE 
PROPYLENE GLYCOL 
WATER 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:65923-108-281 PACKAGE in 1 BOX
128 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/26/2014
Labeler - United Exchange Corp. (840130579)

Revised: 10/2016
 
United Exchange Corp.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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