Tolnaftate D

Dosage form: cream
Ingredients: Tolnaftate 1g in 100g
Labeler: NexMed (USA), Inc.
NDC Code: 40002-002

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.

Drug Facts

Active Ingredient

Tolnaftate

Purpose

Antifungal

Uses
  • Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • Proven effective in the prevention of athlete’s foot
  • Effectively soothes and relieves itching associated with jock itch, scaly skin between the toes and burning feet

Warnings

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 2 weeks (for jock itch) and 4 weeks for (athlete’s foot and ringworm)

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
  • Clean the affected area and dry thoroughly
  • Apply a thin layer over affected area twice a daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • For athlete’s foot, pay attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • For athlete’s foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks.
  • If condition persists longer consult a doctor
  • This product is not effective on the scalp or nails

Other information
  • Store between 20 and 25C (68 to 77F)
  • Lot No. and Exp. Date: see box or see crimp of tube
  • Keep box for complete instructions and labeling

Inactive Ingredients

cetyl  alcohol, dodecyl-2-N N-dimethylaminopropionate hydrochloride, methylparaben, mineral oil, ceteth-10, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol

Questions?

Call 858-222-8041, Mon-Fri, 8:30 AM - 5:30PM (PST)

TOLNAFTATE  D
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40002-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tolnaftate (Tolnaftate) Tolnaftate1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Cetyl Alcohol 
Dodecyl-2-N,N-Dimethylaminopropionate Hydrochloride 
Methylparaben 
Mineral Oil 
Ceteth-10 
Propylene Glycol 
Propylparaben 
Water 
Sorbitan Monostearate 
Stearyl Alcohol 
Packaging
#Item CodePackage Description
1NDC:40002-002-011 TUBE (TUBE) in 1 CARTON
1NDC:40002-002-0228 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/15/2011
Labeler - NexMed (USA), Inc. (031710528)
Registrant - NexMed (USA), Inc. (031710528)

Revised: 08/2011
 
NexMed (USA), Inc.

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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