Label: DR. SCHOLLS INSTANT COOL ATHLETES FOOT TREATMENT WITH MENTHOL- tolnaftate spray

  • NDC Code(s): 73469-0691-1
  • Packager: Scholl's Wellness Company
  • 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 March 22, 2022

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  • Drug Facts

  • Active ingredient

    Tolnaftate 1%

    Purpose

    Antifungal

  • Uses

    • cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • prevents most athlete's foot (tinea pedis) and ringworm (tinea corporis) with daily use
    • for effective relief of itching, burning, cracking, scaling and discomfort which accompany these conditions
  • Warnings

    For external use only

    Flammable: Do not use while smoking or near heat or flame

    Do not use on 

    children under 2 years of age unless otherwise directed by a doctor 

    When using this product

    • avoid contact with the eyes
    • use only as directed. Interntional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.
    • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

    Stop use and ask a doctor if 

    • irritation occurs
    • there is no improvement within 4 weeks (for athlete's foot and ringworm)

    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 on the affected area twice daily (morning and night)
    • pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
    • supervise children in the use of this product
    • for treatment of athlete's foot and ringworm, use daily for 4 weeks.
    • to prevent athlete's foot, apply once a twice daily (morning and/or night)
  • Other information

    • store between 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    BHT, Dimethyl Ether, Menthol, Menthoxypropanediol, PPG-12-Buteth-16, SD Alcohol 40-B

  • Questions?

    1-866-360-3226

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    DR. SCHOLLS INSTANT COOL ATHLETES FOOT TREATMENT WITH MENTHOL 
    tolnaftate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73469-0691
    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
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    DIMETHYL ETHER (UNII: AM13FS69BX)  
    MENTHOL (UNII: L7T10EIP3A)  
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73469-0691-1150 g in 1 CAN; Type 0: Not a Combination Product03/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/10/2022
    Labeler - Scholl's Wellness Company (117174744)
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