NDC 68770-125 Allergy Desensitization

Onion, Apis Mellifera, Schoenocaulon Officinale Seed, Euphrasia Stricta

NDC Product Code 68770-125

NDC CODE: 68770-125

Proprietary Name: Allergy Desensitization 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: Onion, Apis Mellifera, Schoenocaulon Officinale Seed, Euphrasia Stricta 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 68770-125-10

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

NDC Product Information

Allergy Desensitization with NDC 68770-125 is a a human over the counter drug product labeled by Natural Ophthalmics, Inc. The generic name of Allergy Desensitization is onion, apis mellifera, schoenocaulon officinale seed, euphrasia stricta. 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.

Allergy Desensitization 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.

  • ONION 6 [hp_X]/mL
  • APIS MELLIFERA 6 [hp_X]/mL
  • SCHOENOCAULON OFFICINALE SEED 6 [hp_X]/mL
  • EUPHRASIA STRICTA 4 [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)
  • 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: 07-06-2020 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.

Allergy Desensitization 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

Allium cepa6xRelieves itching, burningApis6xRelieves inflammation with burning and stingingSabadilla6xRelieve hay fever type symptomsEuphrasia (Eye-bright)4xGeneral dryness, redness and irritation of the eye and lids

Active Ingredients

Allium cepa6xApis6xSabadilla6xEuphrasia (Eye-bright)4x

Inactive Ingredients

Sterile water (non-preserved)Polysorbate 80CitratesSodium chloride

Uses

According to homeopathic principles these drops are indicated for itching, burning, watering and edema associated with ocular allergy.*

Directions

Instill 1-3 drops in the eye. Use several times per day as needed.

Warnings

- For ophthalmic use.

- For Professional Use Only

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Do Not Use

Do not use if solution becomes cloudy. If pregnant or breastfeeding, 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.

Storage

Safe StorageRoom temperature 59
o to 86
o F (15
o to 30
o C)

Otc - Questions

Natural Ophthalmlcs, Inc.Dillon, CO 80435 USAwww.natoph.com877-220-9710

* Please review the disclaimer below.