Label: FLAWLESS NAILS- tolnaftate solution

  • NDC Code(s): 76348-990-01, 76348-990-02
  • Packager: RENU LABORATORIES, INC.
  • 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 January 5, 2023

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  • ACTIVE INGREDIENT

    Tolnaftate

  • QUESTIONS

    MyFlawlessNails LLC

    Fairfield, CT 06824

    www.MyFlawlessNails.com

  • STATEMENT OF IDENTITY

    FLAWLESS NAILS

    Nail Fungus Eliminator

    Medical Strength

    Clinically Proven

    15ML (O.5FL.OZ)

  • OTHER SAFETY INFORMATION

    Other information: Store at 68° - 77°

  • INACTIVE INGREDIENT

    Inactive Ingredients

    C12-15 Alkyl Benzoate, Camphor, Ceramide III, Cinnamonium Zeylanicum (Cinnamon Bark) Oil, Cymbopogon Nardus (Citronella) Oil, Ethoxydiglycol, Eugenia Caryophyllum (Clove Bud) Extract, Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oils, Lavandula Angustifolia (Lavender) Oil, Limonene, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha piperita (Peppermint) Leaf Oil,

    Olea Europaea (Olive Pomace) Oil, Oreganum Vulgare (Oregano) Leaf Oil, Pinene, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzgium Aromaticum (Clove Bud) Oil, Thymol, Tocopherol Acetate, Trimethyl-Adipic Acid Copolymer.

  • PURPOSE

    Antifungal

  • INDICATIONS & USAGE

    Uses

    • proven clinically to cure most:
    • athlete's foot (tinea pedis)
    • ringworm (tinea corporis)

    • Effectively soothes and relieves:
    • itching
    • burning
    • cracking
    • helps prevent most athlete's foot from coming back with daily use
  • WARNINGS

    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 the eyes

    Stop use and ask a doctor if

    • there is no improvement within 4 weeks

    Keep out of reach of children.

    Get medical help or contact a Poison Control Center right away.

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

    When using this product, avoid contact with the eyes

    Keep out of reach of children.

    Get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions

    clean the affected area and dry thoroughly

    apply a thin layer over the affected area twice daily

    supervise children in the use of this product

    for athletes foot pay special attention to the spaces between toes

    use daily for 4 weeks

  • PRINCIPAL DISPLAY PANEL

    FLAWLESS NAILS LABEL AND FLAWLESS NAILS BOX

    FLAWLESS NAILS BOX

    FLAWLESS NAIL LABEL

  • INGREDIENTS AND APPEARANCE
    FLAWLESS NAILS 
    tolnaftate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-990
    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
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
    TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
    PINENE (UNII: 996299PUKB)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CLOVE (UNII: K48IKT5321)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CLOVE OIL (UNII: 578389D6D0)  
    THYMOL (UNII: 3J50XA376E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-990-021 in 1 BOX04/03/2023
    1NDC:76348-990-0115 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00504/03/2023
    Labeler - RENU LABORATORIES, INC. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    RENU LABORATORIES945739449manufacture(76348-990)
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