OCCULOPLEX I- euphrasia officinalis, ginkgo biloba, hydrastis canadensis, taraxacum officinale, beta carotene, cyanocobalamin, glutathione, ubiquinone, zincum gluconicum, bioflavonoids, eye (bovine), ammonium muriaticum , calcarea fluorica, causticum, conium maculatum, germanium sesquioxide, magnesia carbonica, selenium dioxide, silicea liquid 
BioActive Nutritional, Inc.

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.

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Drug Facts:

ACTIVE INGREDIENTS:

Euphrasia Officinalis 3X, Ginkgo Biloba 3X, Hydrastis Canadensis 3X, Taraxacum Officinale 3X, 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.

DIRECTIONS:

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

INACTIVE INGREDIENTS:

Demineralized water, 25% Ethanol.

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.

INDICATIONS:

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

QUESTIONS:

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

OCCULOPLEX I

HOMEOPATHIC

1FL OZ (30 ml)

Occuloplex I

OCCULOPLEX I 
euphrasia officinalis, ginkgo biloba, hydrastis canadensis, taraxacum officinale, beta carotene, cyanocobalamin, glutathione, ubiquinone, zincum gluconicum, 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:43857-0059
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
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL3 [hp_X]  in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE3 [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 GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE6 [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 FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE12 [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:43857-0059-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/25/201306/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/25/201306/28/2021
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0059) , api manufacture(43857-0059) , label(43857-0059) , pack(43857-0059)

Revised: 6/2021
Document Id: ea224b4f-6081-4e94-835e-9add435cc2fc
Set id: dd344e09-ab4d-4b36-9812-06388826bd5f
Version: 6
Effective Time: 20210615
 
BioActive Nutritional, Inc.