Label: DR. SCHOLLS INSTANT COOL ATHLETES FOOT WIPES- tolnaftate swab

  • NDC Code(s): 52261-8100-1
  • Packager: Cosco International, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 10, 2022

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  • Active Ingredient

    Tolnaftate 1%.........................Purpose: Antifungal

  • Purpose

    Antifungal foot wipes

  • Uses

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

    For External use only

  • DO NOT USE

    Do not use on children under 2 years of age unless otherwise directed by a doctor

  • WHEN USING

    When using this product avoid contact with the eyes

  • STOP USE

    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

    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
    • use the pad to cleanse and cover the affected area with a thin layer 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 or twice daily (morning and/or night)
  • Other Information

    • KEEP TIGHTLY CLOSED
    • do not flush pads in toilet
    • store between 20° ro 25°C (68° to 77°F)
  • Inactive ingredients

    Butylated Hydroxytoluene, Caprylyl Glycol, Eucalyptus Oil, Menthol, Menthoxypropanediol, Peppermint Oil, Phenoxyethanol, Polysorbate 20, Polysorbate 80, Proylene Glycol, Sodium Hydroxide, Water

  • QUESTIONS

    Questions?     1-866-360-3226

  • PRINCIPAL DISPLAY PANEL

    60 ct label

  • INGREDIENTS AND APPEARANCE
    DR. SCHOLLS INSTANT COOL ATHLETES FOOT WIPES 
    tolnaftate swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-8100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    menthol (UNII: L7T10EIP3A)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52261-8100-160 in 1 CANISTER02/01/2022
    12.5 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/27/2022
    Labeler - Cosco International, Inc. (016433141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(52261-8100)