NDC 68770-135 Cataract Crystalline Lens

Cineraria Maritima, Euphrasia Strictica, Causticum, Calcarea Phosphorica, Sepia, Calcarea Flourica, Silicea

NDC Product Code 68770-135

NDC CODE: 68770-135

Proprietary Name: Cataract Crystalline Lens 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: Cineraria Maritima, Euphrasia Strictica, Causticum, Calcarea Phosphorica, Sepia, Calcarea Flourica, 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.

NDC Code Structure

  • 68770 - Natural Ophthalmics, Inc

NDC 68770-135-10

Package Description: 1 BOTTLE, DROPPER in 1 PACKAGE > 10 mL in 1 BOTTLE, DROPPER

NDC Product Information

Cataract Crystalline Lens with NDC 68770-135 is a a human over the counter drug product labeled by Natural Ophthalmics, Inc. The generic name of Cataract Crystalline Lens is cineraria maritima, euphrasia strictica, causticum, calcarea phosphorica, sepia, calcarea flourica, silicea. The product's dosage form is liquid and is administered via ophthalmic form.

Labeler Name: Natural Ophthalmics, 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.

Cataract Crystalline Lens 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.

  • JACOBAEA MARITIMA 6 [hp_X]/mL
  • EUPHRASIA STRICTA 6 [hp_X]/mL
  • CAUSTICUM 8 [hp_X]/mL
  • TRIBASIC CALCIUM PHOSPHATE 11 [hp_X]/mL
  • SEPIA OFFICINALIS JUICE 8 [hp_X]/mL
  • CALCIUM FLUORIDE 11 [hp_X]/mL
  • SILICON DIOXIDE 11 [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)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

Administration Route(s)

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

  • Ophthalmic - Administration to the external eye.
  • Ophthalmic - Administration to the external eye.

Product Labeler Information

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

Labeler Name: Natural Ophthalmics, Inc
Labeler Code: 68770
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: 07-14-2020 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: 12-31-2021 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.

Cataract Crystalline Lens 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

Homeopathic Purpose

Cineraria Maritima HPUS6XIncreases circulation in the intraocular tissuesEuphrasia (Eyebright) HPUS6XGeneral dryness, redness and irritation of the eye and lidsCausticum HPUS8XEye painCalcarea phosphorica HPUS11XBlurry vision, eye pain from readingSepia HPUS8XGlares, black spots, veils, points, sparks, flashes and streaks of lightCalcarea fluorica HPUS11XCataract, corneal opacities, keratitis, flickering and floatersSilicea HPUS11XSpotted vision, cataract, opacities, keratitis*Claims are based on traditional homeopathic practice, not accepted medicalevidence. Not FDA evaluated

Active Ingredients

Cineraria Maritima HPUS6XEuphrasia (Eyebright) HPUS6XCausticum HPUS8XCalcarea phosphorica HPUS11XSepia HPUS8XCalcarea fluorica HPUS11XSilicea HPUS11X"HPUS" indicates the active ingredients of this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Inactive Ingredients

Purified waterSodium chlorideSodium citratePolysorbate 80Citric acid

Uses

According to homeopathic principles these drops are indicated for the treatment of the symptoms of Cataract.* *Claims are based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Directions

Instill 1drop in each eye three times per day or as directed by your doctor.

Warnings

- For ophthalmic use.

For professional use only.
Do not use if tamper evident seal is torn, broken. or missing.

Otc - Keep Out Of Reach Of Children

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

If Pregnant Or Breast Feeding

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

Stop Use And Ask A Doctor If:

Stop use and ask a doctor if: You experience eye pain, changes in vision, continued redness or irritation of the eye. The condition worsens. Symptoms last longer than 72 hours.

Do Not Use

Do not use if solution becomes cloudy.

Storage

  • Safe StorageRoom temperature
  • 59
  • O to 86
  • O (15
  • O to 30
  • O C)

Otc - Questions

Natural Ophthalmics, Inc



Dillon, CO, 80435



1-877-220-9710



www.natoph.com

* Please review the disclaimer below.