Label: NOVONAIL SOLUTION- tolnaftate 1% liquid

  • NDC Code(s): 72839-507-01
  • Packager: Derma Care Research Labs, LLC
  • 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 July 24, 2023

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  • ACTIVE INGREDIENT

    Tolnaftate 1%

  • PURPOSE

    Antifungal

  • INDICATIONS & USAGE

    For effective treatment of most athlete's foot and ringworm. Relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomfort. Helps prevent most athlete's foot (dermatophytosis) with daily use.

  • WARNINGS

    For external use only.

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

    When using this product avoid contact with eyes.

    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

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

  • DOSAGE & ADMINISTRATION

    For athlete's foot and ringworm: use daily for 4 weeks. Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. This product is not effective for the treatment of ringworm of the scalp or nails. 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. To prevent athlete's foot, apply once or twice daily (morning and/or night). Apply to skin around the nail and cuticle.

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Extract, BHT, Carthamus Tinctorius (Safflower) Seed Oil, Hydrogenated Polyisobutene, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sesamum Indicum (Sesame) Seed Oil, Oryza Sativa (Rice) Bran Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    NOVONAIL SOLUTION 
    tolnaftate 1% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-507
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72839-507-0113.3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00503/11/2020
    Labeler - Derma Care Research Labs, LLC (116817470)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(72839-507)