Label: PROCLEARZ LASER ANTIFUNGAL- tolnaftate liquid

  • NDC Code(s): 29784-183-01
  • Packager: Rooftop Consumer Health, inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 4, 2025

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  • Drug Facts

  • Active ingredient

    Tolnaftate 1%

    Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis)
    • helps prevent most athlete’s foot with daily use
    • for effective relief of itching, burning, and cracking
  • 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 directed by a doctor.

    When using this product

    • Avoid contact with eyes
    • Use only as directed. Intentional misuse by deliberately concetrating 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 doctor if

    • irritation occurs
    • there is no improvement within 4 weeks

    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 changes shoes and socks at least once daily
    • use daily for 4 weeks; if condition persists longer, ask a doctor
    • to prevent athlete’s foot apply once or twice daily (morning and/or night)
    • this product is not effective on the scalp or nails
  • Other information

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

  • Inactive ingredients

    butylated hydroxytoluene, isobutane, PPG-12-buteth-16, SD alcohol 40-B (30% v/v)

  • Questions or comments?

    www.rooftopch.com cservice@rooftopch.com

  • Package Labeling:

    Label0

  • INGREDIENTS AND APPEARANCE
    PROCLEARZ LASER ANTIFUNGAL 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29784-183
    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)  
    ISOBUTANE (UNII: BXR49TP611)  
    PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29784-183-0185 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00501/01/2025
    Labeler - Rooftop Consumer Health, inc (107570900)
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