Label: OCCULOPLEX I (euphrasia officinalis, ginkgo biloba, taraxacum officinale, hydrastis canadensis, beta carotene, cyanocobalamin, glutathione, ubidecarenonum, zincum gluconicum, citrus bioflavonoids, eye- bovine, ammonium muriaticum, calcarea fluorica, causticum, conium maculatum, germanium sesquioxide, magnesia carbonica, selenium dioxide, silicea liquid

  • NDC Code(s): 43857-0449-1
  • Packager: BioActive Nutritional, Inc.
  • 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 June 15, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS:

    Euphrasia Officinalis 3X, Ginkgo Biloba 3X, Taraxacum Officinale 3X, Hydrastis Canadensis 5X, Beta Carotene 6X, Cyanocobalamin 6X, Glutathione 6X, Ubidecarenonum 6X, Zincum Gluconicum 6X, Citrus Bioflavonoids 8X, Eye (Bovine) 8X, Ammonium Muriaticum 12X, Calcarea Fluorica 12X, Causticum 12X, Conium Maculatum 12X, Germanium Sesquioxide 12X, Magnesia Carbonica 12X, Selenium Dioxide 12X, Silicea 12X.   

  • INDICATIONS:

    For temporary relief of minor inflammation, burning & swelling of the eyelids.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health care professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not use if tamper evident seal is broken or missing.

    Store in cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of minor inflammation, burning & swelling of the eyelids.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    OCCULOPLEX

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Occuloplex

  • INGREDIENTS AND APPEARANCE
    OCCULOPLEX  I
    euphrasia officinalis, ginkgo biloba, taraxacum officinale, hydrastis canadensis, beta carotene, cyanocobalamin, glutathione, ubidecarenonum, zincum gluconicum, citrus bioflavonoids, eye (bovine), ammonium muriaticum, calcarea fluorica, causticum, conium maculatum, germanium sesquioxide, magnesia carbonica, selenium dioxide, silicea liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0449
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA3 [hp_X]  in 1 mL
    GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T) GINKGO3 [hp_X]  in 1 mL
    TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE3 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL5 [hp_X]  in 1 mL
    .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE6 [hp_X]  in 1 mL
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN6 [hp_X]  in 1 mL
    GLUTATHIONE (UNII: GAN16C9B8O) (GLUTATHIONE - UNII:GAN16C9B8O) GLUTATHIONE6 [hp_X]  in 1 mL
    UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE6 [hp_X]  in 1 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC6 [hp_X]  in 1 mL
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50) (HESPERIDIN - UNII:E750O06Y6O) CITRUS BIOFLAVONOIDS8 [hp_X]  in 1 mL
    BOS TAURUS EYE (UNII: VTW461N43P) (BOS TAURUS EYE - UNII:VTW461N43P) BOS TAURUS EYE8 [hp_X]  in 1 mL
    AMMONIUM CHLORIDE (UNII: 01Q9PC255D) (AMMONIUM CATION - UNII:54S68520I4) AMMONIUM CATION12 [hp_X]  in 1 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CHLORIDE12 [hp_X]  in 1 mL
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM12 [hp_X]  in 1 mL
    CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP12 [hp_X]  in 1 mL
    GERMANIUM SESQUIOXIDE (UNII: 96WE91N25T) (GERMANIUM SESQUIOXIDE - UNII:96WE91N25T) GERMANIUM SESQUIOXIDE12 [hp_X]  in 1 mL
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE12 [hp_X]  in 1 mL
    SELENIUM DIOXIDE (UNII: 9N3UK29E57) (SELENIUM DIOXIDE - UNII:9N3UK29E57) SELENIUM DIOXIDE12 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0449-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product06/08/201710/17/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/08/201710/17/2023
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0449) , api manufacture(43857-0449) , label(43857-0449) , pack(43857-0449)