Label: SMOOTH AF- tolnaftate cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2023

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  • Active Ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of most athlete's foot 9tinea 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

  • Directions

    • wash affected area with soap and water and dry thoroughly

    • unfold and use towel to thoroughly clean and massage solution into entire foot soles, around and between toes

    • sue new towel daily for 4 weeks; if condition persists longer, ask a doctor

    • dispose of uses towel in bin, do not flush

    • to prevent athlete's foot, use towel as directed once or twice daily (morning and/or night)

    • for athlete's foot, wear well fitting, ventilated shoes and change shoes and socks at least once daily

    • this product is not effective on the scalp or nails

  • When using this product

    When using this product avoid contact with the eyes.

    • use only as directed; intentional misuse by deliberately concentrating and inhaling may harmful or fatal

  • Stop use and ask a doctor

    • if irritation occurs • there is no improvement within 4 weeks

  • Do not use

    Do not use on children under 2 years of age except under advice and supervision of a doctor.

  • Other information

    Store between 20°–25°C (68°–77°F)

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Inactive ingredients

    Water, Propanediol, Dioxolane, Mentha Piperita (Peppermint) Oil, Eucalyptus Globulus Leaf Oil, Gossypium Herbaceum (Cotton) Seed Oil, Sodium Lauroyl Sarcosinate, Sodium Lauroamphoacetate, Ethylhexyl Stearate, Sorbitan Laurate, Polyglyceryl-4 Laurate, Dilauryl Citrate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol

  • Questions

    info@pelliskin.com

  • Label

    SMOOTH

    AF TM

    Relief reinvented

    Alcohol-free

    athlete's foot

    cure and

    prevention

    1 Treatment towel

    getsmoothaf.com

    A spa day in a towel

    APPROVED

    AMERICAN PODIATRIC

    MEDICAL

    ASSOCIATION

    PELLI

    Distributed by:

    Pelli Skin Co., LLC.

    Mission, Texas

    getsmoothaf.com

    1 Treatment Towel: 7.0in x 8.0in (17.8cm x 20.32cm)

    A spa day in a towel

    • All-In-One Convenience
    • Fights Odor & Smells Fresh
    • Safe for Daily Use

    Scientific Breakthrough Focused on Health

    • Alcohol & Paraben Free
    • Proactive Formula
    • Non-Greasy & Absorbs Quickly

    Proactive Layer

    Advanced anti-fungal medication

    Total Foot Care

    • Cleans & Conditions
    • Revitalizes
    • Treats Athlete's Foot
    • Prevents Athlete's Foot

    The Clean Cure

    Doctor recommended anti-fungal

    medicated foot towels. Alcohol and

    Paraben free. Cures and prevents

    Athlete's Foot. Safe and effective.

    GREAT FOR

    Athlete's foot

    Diabetics

    Foot Odor

    PATENT

    PENDING

    PROUDLY

    MADE IN THE

    USA

    RAINFOREST ALLIANCE

    CERTIFIED

    MIX Paper

    FSC FSCR C109834

    PODIATRIST RECOMMENDED

    14 Individually Wrapped Treatment Towels

    7.0in x 8.0in (17.8cm x 20.32cm)

    LABEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    SMOOTH AF 
    tolnaftate cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73046-124
    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
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    WATER (UNII: 059QF0KO0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIOXOLANE (UNII: Y57RBG19JL)  
    DISODIUM LAUROAMPHODIACETATE (UNII: R4HKX6I64R)  
    SODIUM LAURATE (UNII: K146MR5EXO)  
    COTTONSEED OIL (UNII: H3E878020N)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    DILAURYL CITRATE (UNII: 5OYS3G306B)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Product Characteristics
    Colorwhite (Cloth) Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73046-124-001 g in 1 PACKET; Type 0: Not a Combination Product07/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00507/11/2019
    Labeler - Pelli Skin Co.,LLC. (117027673)
    Registrant - Diamond Wipes International (161104729)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes International161104729manufacture(73046-124)
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