Label: TOLNAFTATE- foot odor control spray aerosol, spray

  • 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 February 19, 2021

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

  • ​Active ingredient

    Tolnaftate 1%

  • ​Purpose

    Antifungal

  • ​Uses

    • prevents recurrence of athlete's foot (tinea pedis) with daily use
    • cures mose athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • relieves sypmtoms of athlete's foot, including itching, burning and cracking
  • Warnings

    ​For external use only.

    ​Flammable:

    Keep away from heat, sparks and open flame. Contents under pressure. Do not puncture or incinerate.  Do not store at temperature above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

    ​When using this product

    • avoid contact with the eyes or mouth

    ​Stop use and ask a doctor if

    • irritation occurs
    • no improvement within 4 weeks

    ​Do not use

    on children under 2 years of age unless directed by 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
    • shake can well and spray 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 daily
    • use daily for 4 weeks
    • if conditions persist, consult a doctor
    • to prevent athlete's foot, apply once or twice daily (morning and/or night)
    • in case of clogging, clear nozzle under running water
  • ​Other information

    store between 20º and 30ºC (68ºF and 86º)

  • ​Inactive ingredients

    disteardimonium hectorite, fragrance, isobutane, isopropyl myristate, SD alcohol 40-B, sodium bicarbonate

  • Questions?

    call 1-866-964-0939

  • Principal Display Panel

    TopCare

    MEDICATED

    Foot Odor

    Control

    Powder Spray

    TOLNAFTATE % • ANTIFUNGAL

    • Cures Most Athlete's Foot & Prevents Recurrences

    • Reduces Foot Odor
    • Relieves Itching, Burning & Cracking

    NET WT 4 OZ (113g)

    Foot Odor Control Spray

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE 
    foot odor control spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1.13 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISOBUTANE (UNII: BXR49TP611)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-023-04113 g in 1 CAN; Type 0: Not a Combination Product01/05/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/05/2012
    Labeler - Topco Associates LLC (006935977)