Label: FUNGACLEAR- olive leaf liquid

  • 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 December 19, 2018

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  • Active Ingredients

    Olive Leaf HPUS 1X 7.9%

  • Inactive Ingredients

    Alcohol, Bai Shao, Chaparrel, Damiana, Gan Jiang, Hai Tong Pi, Hong Hua, Jin Yin Hua, Jing Jie, Ku Shen, Lavender, Lemongrass, Long Dan Cao, Rosehips, Rou Gui, Tao Ren, White Sage Leaf

  • Purpose

    Active Ingredients--------Purpose
    Olive Leaf .....................Redness, Discoloration, Anti-itch

    The letters HPUS indicate ingredients officially included in the Homeopathic Pharmacopoeia of the United States.

  • Keep Out of Reach of Children

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center.

  • Uses*

    ■ Restoration of nails due to fungal infection.


    * These statements are based upon traditional homeopathic practice.
    They have not been reviewed by the Food and Drug Administration.

  • PREGNANCY OR BREAST FEEDING

  • Warnings

    For external use only. Avoid Eyes.

  • Directions

    Directions

    Using applicator, drop extract on top of and under nail area, allow for absorption to occur before continuing application. Apply 5 applications two times per day.

  • Do Not Use

    Do not use if tamper evident seal is broken.

  • SPL UNCLASSIFIED SECTION


    Aged extract to restore nails affects by fungal infection

    THE ALCHEMIST COLLECTION
    175 Wrenn St.
    Tavernier. FL 33070
    www.thealchemistcollection.com

  • PRINCIPAL DISPLAY PANEL

    Box

  • INGREDIENTS AND APPEARANCE
    FUNGACLEAR 
    olive leaf liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71281-303
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) (OLEA EUROPAEA LEAF - UNII:MJ95C3OH47) OLEA EUROPAEA LEAF1 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    SALVIA APIANA LEAF (UNII: Z29Z21AHMP)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    LARREA TRIDENTATA WHOLE (UNII: B755J144H1)  
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ)  
    ERYTHRINA VARIEGATA BARK (UNII: E6PM3D3WY8)  
    LONICERA DASYSTYLA FLOWER BUD (UNII: J133K038DY)  
    NEPETA TENUIFOLIA FLOWERING TOP (UNII: 2FN3BA1MZE)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    GINGER (UNII: C5529G5JPQ)  
    EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)  
    GENTIANA CRASSICAULIS WHOLE (UNII: 244RVN721T)  
    CHINESE CINNAMON (UNII: WS4CQ062KM)  
    PRUNUS PERSICA SEED (UNII: V9C81470RR)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71281-303-011 in 1 BOX06/13/2018
    128 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/13/2018
    Labeler - CANDICE NELMS, INC. (080545348)
    Establishment
    NameAddressID/FEIBusiness Operations
    CANDICE NELMS, INC.080545348manufacture(71281-303)
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