NDC 43857-0449 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

NDC Product Code 43857-0449

NDC CODE: 43857-0449

Proprietary Name: Occuloplex I What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: 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 What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Cyanocobalamin is a man-made form of vitamin B12 used to treat low levels (deficiency) of this vitamin. Vitamin B12 helps your body use fat and carbohydrates for energy and make new protein. It is also important for normal blood, cells, and nerves. Most people get enough vitamin B12 in their diet, but a deficiency may occur in certain health conditions (e.g., poor nutrition, stomach/intestinal problems, infection, cancer). Serious vitamin B12 deficiency may result in anemia, stomach problems, and nerve damage.
  • Coenzyme Q10 has been used for heart problems (e.g., heart failure, angina), high blood pressure, Parkinson's disease, gum disease, and certain diseases passed down through families (Huntington's disease, muscular dystrophy). It has also been used for reducing the number of migraine headaches and for reducing cell damage that may occur after surgery or treatment with certain anti-cancer drugs. If you have or think you have any of the conditions listed above, consult your doctor for advice on proper care and treatment. Coenzyme Q10 is a substance that your body normally makes. Your body uses it to help keep in good health. Some herbal/diet supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details about the brand you use. The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.
  • Drug uses not available
  • Drug uses not available

NDC Code Structure

  • 43857 - Bioactive Nutritional, Inc.

NDC 43857-0449-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Occuloplex I with NDC 43857-0449 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Occuloplex I is 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. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Bioactive Nutritional, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Occuloplex I Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • EUPHRASIA STRICTA 3 [hp_X]/mL
  • GINKGO 3 [hp_X]/mL
  • TARAXACUM OFFICINALE 3 [hp_X]/mL
  • GOLDENSEAL 5 [hp_X]/mL
  • .BETA.-CAROTENE 6 [hp_X]/mL
  • CYANOCOBALAMIN 6 [hp_X]/mL
  • GLUTATHIONE 6 [hp_X]/mL
  • UBIDECARENONE 6 [hp_X]/mL
  • ZINC 6 [hp_X]/mL
  • CITRUS BIOFLAVONOIDS 8 [hp_X]/mL
  • BOS TAURUS EYE 8 [hp_X]/mL
  • AMMONIUM CHLORIDE 12 [hp_X]/mL
  • CALCIUM CHLORIDE 12 [hp_X]/mL
  • CAUSTICUM 12 [hp_X]/mL
  • CONIUM MACULATUM FLOWERING TOP 12 [hp_X]/mL
  • GERMANIUM SESQUIOXIDE 12 [hp_X]/mL
  • MAGNESIUM CARBONATE 12 [hp_X]/mL
  • SELENIUM DIOXIDE 12 [hp_X]/mL
  • SILICON DIOXIDE 12 [hp_X]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bioactive Nutritional, Inc.
Labeler Code: 43857
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-08-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Occuloplex I Product Label Images

Occuloplex I Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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.

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.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Questions:

Distributed by:BioActive Nutritional, Inc.1803 N. Wickham Rd.Melbourne, FL 32935bioactivenutritional.com

Package Label Display:

BIOActive NutritionalOCCULOPLEXHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.