Label: THERA PLUS ANTIFUNGAL TOLNAFTATE- tolnaftate cream

  • NDC Code(s): 80684-040-01
  • Packager: FOURSTAR GROUP USA, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

  • Active ingredient

    Tolnaftate 1%

    Purpose

    Anti-Fungal

  • Uses

    • proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis)
    • helps prevent most athlete's foot with daily use 
    • for effective relief of itching , burning , and cracking
  • Warnings

    For external use only.

    Do not use

    on children under 2 years of age except under the advice and supervision of a doctor.

    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.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • 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-ftting, ventilated shoes and change shoes and socks at least once daily
    • use daily for 4 weeks ; if condition persists longer, ask a doctor.
    • to prevent athlete’s foot, apply once or twice daily (morning and/or night).
    • this product is not effective on the scalp or nails.
  • Other information

    • store at room temperature 20° to 25°C (68° to 77°F)
    • lot no & expiration date: see box or crimp of tube
  • Inactive ingredients

    cetyl alcohol, ethylparaben, glycerol, glyceryl monostearate, mineral oil, petrolatum, purified water, sodium lauryl sulfate

  • Questions?

    1-888-296-9067 Weekdays 9 AM to 4 PM EST

  • Package Labeling:

    Outer Package2Inner Package2

  • INGREDIENTS AND APPEARANCE
    THERA PLUS ANTIFUNGAL TOLNAFTATE 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80684-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80684-040-011 in 1 BOX01/30/2022
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00501/30/2022
    Labeler - FOURSTAR GROUP USA, INC. (140099503)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!