Label: TOLNAFTATE D- tolnaftate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated August 16, 2011

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  • 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 20⁰ and 25⁰C (68⁰ to 77⁰F)
    • 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)

  • PRINCIPAL DISPLAY PANEL

    Image of carton label

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE  D
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40002-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV) Tolnaftate1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Dodecyl-2-N,N-Dimethylaminopropionate Hydrochloride (UNII: 18F5YMF989)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Ceteth-10 (UNII: LF9X1PN3XJ)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Water (UNII: 059QF0KO0R)  
    Sorbitan Monostearate (UNII: NVZ4I0H58X)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40002-002-011 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)
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