Label: NAIL REPAIR PEN liquid

  • NDC Code(s): 84117-001-01
  • Packager: Shenzhen Hengkaifeng Commerce and Trade Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 5, 2024

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  • Active ingredients

    Tolnaftate ≤1%

  • PURPOSE

    Anti-fungal

  • Uses

    Uses for relief and treatment of pain,soreness, and inflammation from nail fungus.
    Symptoms: ■ discolored nails ■ brittle nails ■ distorted nails

  • Warnings

    For external use only, Some individuals may be sensitive to essential oils.
    Begin with a small drop to determine if product causes any irritation. Discontinue use if any irritation occurs.
    Stop use and consult a doctor if condition worsens, Not for use on children under the age of 2 without physician direction.

  • Stop use and ask a doctor if

    rash occur

  • Do not use

    on damaged or broken skik

  • When using this product

    Directions shake well before use.
    Wash and thoroughly dry the affected area.
    Apply 1-2 drops and gently rub into affected area three times per day.
    Wash hands after applying

  • Keep out of reach of children.

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

  • inactive ingredients

    Water

    Lonicerae Japonicae flos

    Angelicae

    Glycerin

    Allantoin

    Garlic Extract

    Tea Tree Oil

  • DOSAGE & ADMINISTRATION

    shake well before use.Wash and thoroughly dry the affectedarea. Apply 1-2 drops and gently rubinto affected area three times per day.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    NAIL REPAIR PEN 
    nail repair pen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84117-001
    Route of AdministrationTOPICAL, CUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84117-001-015 g in 1 BOTTLE; Type 0: Not a Combination Product03/06/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/06/2024
    Labeler - Shenzhen Hengkaifeng Commerce and Trade Co., Ltd (444722774)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Hengkaifeng Commerce and Trade Co., Ltd444722774manufacture(84117-001) , label(84117-001)
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