Label: ATHLETES FOOT- tolnaftate 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 December 21, 2018

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  • ACTIVE INGREDIENT

    Active IngredientPurpose

    Tolnaftate 1% ................................................................ Antifungal

  • PURPOSE

    Uses

    • cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • if used daily, can prevent recurrence of athlete's foot
    • relieves symptoms of athlete's foot, including itching, burning and cracking
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Do not use on children under 2 years of age unless directed by a doctor.

  • INDICATIONS & USAGE

    DG Health

    Athlete's Foot Liquid Spray Tolnaftate 1% Antifungal

    Compare to active ingredeint in Tinactin®*

    Cures and prevents most athlete's foot

    Relieves burning and itching

    Net Wt 5.3oz (150g)

  • WARNINGS

    Warnings

    For external use only.

    Flammable. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120oF (49oC).

    When using this product

    • avoid contact with eyes and face
    • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement after 4 weeks

  • DOSAGE & ADMINISTRATION

    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 a day
    • use daily for 4 weeks; if condition persists longer, consult a doctor
    • to prevent athlete's foot, apply once or twice daily (morning and night)
    • this product is not effective on the scalp or nails
  • INACTIVE INGREDIENT

    Inactive Ingredients

    isobutane, alcohol denat. (29% w/w), propane, PPG-12-buteth-16, butylated hydroxytoluene

  • PRINCIPAL DISPLAY PANEL

    image

  • INGREDIENTS AND APPEARANCE
    ATHLETES FOOT 
    tolnaftate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50942-003
    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
    ISOBUTANE (UNII: BXR49TP611)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPANE (UNII: T75W9911L6)  
    PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50942-003-01150 g in 1 BOTTLE; Type 0: Not a Combination Product11/04/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C11/04/2014
    Labeler - Taizhou Ludao Cosmetics Co., Ltd. (679885595)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taizhou Ludao Cosmetics Co., Ltd.679885595manufacture(50942-003)