Label: TOENAIL FUNGUS / NAIL REPAIR PEN- tea tree oil solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated May 20, 2022

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  • ACTIVE INGREDIENT

    TEA TREE OIL 10X HPUS

  • PURPOSE

    ANTIFUNGAL

  • USES

    STRONG NAILS FAST

    YELLOW BROKEN BRITTLE TOENAILS & FINGERNAILS

  • WARNINGS

    FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. DISCONTINUE USE IF ADVERSE SKIN REACTION OCCURS. CONSULT YOUR HEALTH CARE PHYSICIAN IF PREGNANT, NURSING, OR FOR A CHILD UNDER THE AGE OF TWO.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • DIRECTIONS

    TEST ON A SMALL PART OF A NAIL FIRST. APPLY TOPICALLY TWICE PER DAY ON THE AFFECTED AREA.

  • INACTIVE INGREDIENTS

    ALOE VERA EXTRACT, EUCALYPTUS OIL, LAVENDER OIL, SWEET ALMOND OIL, VITAMIN C, AND VITAMIN E

  • PRINCIPAL DISPLAY PANEL

    01b UC_Vital Synergy_Nail Repair Pen_3mL

    01b UC_Vital Synergy_Toenail Fungus Solution_30mL

  • INGREDIENTS AND APPEARANCE
    TOENAIL FUNGUS / NAIL REPAIR PEN 
    tea tree oil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82743-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL10 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALMOND OIL (UNII: 66YXD4DKO9)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82743-101-301 in 1 BOX05/16/2022
    1NDC:82743-101-0130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    2NDC:82743-101-636 in 1 BOX05/16/2022
    2NDC:82743-101-033 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/16/2022
    Labeler - VITAL SYNERGY LLC (082975816)