NDC 68770-153 Ortho-k Thick (daytime)

Aluminum Oxide, Apis Mellifera, Arsenic Trioxide, Calendula Officinalis Flowering Top, Tribasic Calcium Phosphate, Euphrasia Stricta, Delphinium Staphisagria Seeds, Sulphur

NDC Product Code 68770-153

NDC 68770-153-10

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

NDC Product Information

Ortho-k Thick (daytime) with NDC 68770-153 is a a human over the counter drug product labeled by Natural Ophthalmics, Inc. The generic name of Ortho-k Thick (daytime) is aluminum oxide, apis mellifera, arsenic trioxide, calendula officinalis flowering top, tribasic calcium phosphate, euphrasia stricta, delphinium staphisagria seeds, sulphur. 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.

Ortho-k Thick (daytime) 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.

  • ALUMINUM OXIDE 14 [hp_X]/mL
  • APIS MELLIFERA 6 [hp_X]/mL
  • ARSENIC TRIOXIDE 9 [hp_X]/mL
  • CALENDULA OFFICINALIS FLOWERING TOP 7 [hp_X]/mL
  • TRIBASIC CALCIUM PHOSPHATE 12 [hp_X]/mL
  • EUPHRASIA STRICTA 6 [hp_X]/mL
  • DELPHINIUM STAPHISAGRIA SEED 8 [hp_X]/mL
  • SULFUR 9 [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.

  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • WATER (UNII: 059QF0KO0R)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • 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.

Ortho-k Thick (daytime) 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

Alumina14xDryness of the eyes and other mucous membranesApis6x & 12xPain, redness, edema, allergiesArsenicum album9xSevere drynessCalendula7xCorneal healing/vitalityCalcarea phosphorica12XForeign body sensationEuphrasia (Eyebright)6xGeneral dryness, redness and irritation of the eye and lidsStaphysagria8x & 12xForeign body sensationSulphur9xDryness, redness of eye and lid, allergies

Active Ingredients

Alumina14xApis6x & 12xArsenicum album9xCalendula7xCalcarea phosphorica12XEuphrasia (Eyebright)6xStaphysagria8x & 12xSulphur9x"HPUS" indicates the active ingredients of this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Inactive Ingredients

Purified water, Polysorbate 80, Sodium citrate, Sodium chloride, Citric acid, Hypromellos

Uses

According to homeopathic principles these drops are indicated to relieve dryness, redness, irritation and to promote corneal health.**Claims are based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Directions

Instill 1 drop in each Ortho-K lens before and after insertion for the night, 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.

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.

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.

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 USA

www.natoph.com

877-220-9710

* Please review the disclaimer below.