Label: TOLNAFTATE- tolnaftate aerosol, spray 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/13

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  • Active ingredient

    Tolnaftate 1%

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  • Purpose

    Antifungal

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  • Uses

    • cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • if used daily, can prevent recurrence of athlete's foot
    • relieves sypmtoms of athlete's foot, including itching, burning and cracking
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  • 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 temperature above 120ºF.

    When using this product

    • do not get into eyes or mouth
    • use only as directed

    Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

    Stop use and ask a doctor if

    • irritation occurs
    • no improvement within four weeks (for athlete's foot) or two weeks (for jock itch)

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under two years of age unless directed by a doctor.

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  • Directions

    • wash affected area and dry thoroughly
    • shake can well and spray a thin layer over affected area twice daily (morning and night) or as directed by a doctor
    • 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, appl morning and/or night
    • this product is not effective on the scalp or nails
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  • ​Other information

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

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  • ​Inactive ingredients

    BHT, isobutane (propellant), PPG-12-buteth-16, SD alcohol 40-B(36%w/w)

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  • ​Questions?

    call 1-800-910-6874

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  • Principal Display Panel

    antifungal liquid spray

    tolnaftate 1%

    Compare to Tinactin®​ Liquid Spray

    cures and prevents most athlete's foot

    cures most jock itch and ringworm

    helps relieve burning and itching

    up&up

    Net WT 5.3 OZ (150.2g)​

    up & up AF Liquid Spray.jpg

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  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE 
    antifungal liquid spray aerosol, spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11673-448
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TOLNAFTATE (TOLNAFTATE) TOLNAFTATE 1.5 g  in 150.2 g
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL  
    BUTYLATED HYDROXYTOLUENE  
    ISOBUTANE  
    PPG-12-BUTETH-16  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11673-448-05 150.2 g in 1 CANISTER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 12/31/2008
    Labeler - Target Corporation (006961700)
    Establishment
    Name Address ID/FEI Business Operations
    Premier Brands of America Inc. 063849780 relabel(11673-448)
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