NDC 68770-114 Tear Stimulation Forte

Aconitum Napellus, Nutmeg, Arsenic Trioxide, Aluminum Oxide, Zinc, Euphrasia Stricta, Sodium Chloride

NDC Product Code 68770-114

NDC CODE: 68770-114

Proprietary Name: Tear Stimulation Forte 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: Aconitum Napellus, Nutmeg, Arsenic Trioxide, Aluminum Oxide, Zinc, Euphrasia Stricta, Sodium Chloride 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 68770-114-10

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

NDC Product Information

Tear Stimulation Forte with NDC 68770-114 is a a human over the counter drug product labeled by Natural Ophthalmics, Inc. The generic name of Tear Stimulation Forte is aconitum napellus, nutmeg, arsenic trioxide, aluminum oxide, zinc, euphrasia stricta, sodium chloride. The product's dosage form is liquid and is administered via ophthalmic form.

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.

Tear Stimulation Forte 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.


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)

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.

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: 06-10-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Tear Stimulation Forte 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

Aconitum nap HPUS 15c

Alumina HPUS 14x

Arsenicum album HPUS 12x

Euphrasia (Eyebright) HPUS 5x

Nux mosch 6x

Nat mur 15c

Zincum met 11x

Uses

According to homeopathic principles these drops are indicated for acute or chronic dry eyes, Sjögren’s or excessive watering secondary to dry eye.*
* Claims are based on traditonal homeopathic practce, not accepted medical evidence. Not FDA evaluated.

Directions

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

Homeopathic Purpose

  • Pulsatilla 8x }Sepia 8x }Euphrasia (Eyebright) 5x }
  • Alumina 10x } Dry eyesArsenicum album 12x }Nux mosch 6x }Zincum met 10x }

Inactive Ingredients

Purified water

Sodium citrate
Sodium chloridePolysorbate 80Citric acid

Warnings

For ophthalmic 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.

If Pregnant Or Breast Feeding

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

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.

Storage

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

* Please review the disclaimer below.