NDC 59262-376 Dry Eye Relief Trial Size 15x

Belladonna, Euphrasia Officinalis, Mercurius Sublimatus,

NDC Product Code 59262-376

NDC CODE: 59262-376

Proprietary Name: Dry Eye Relief Trial Size 15x 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: Belladonna, Euphrasia Officinalis, Mercurius Sublimatus, 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

  • 59262 - Similasan Corporation

NDC 59262-376-13

Package Description: .4 mL in 1 VIAL, SINGLE-USE

NDC Product Information

Dry Eye Relief Trial Size 15x with NDC 59262-376 is a a human over the counter drug product labeled by Similasan Corporation. The generic name of Dry Eye Relief Trial Size 15x is belladonna, euphrasia officinalis, mercurius sublimatus, . The product's dosage form is solution/ drops and is administered via ophthalmic form.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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.

Dry Eye Relief Trial Size 15x 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)
  • SODIUM NITRATE (UNII: 8M4L3H2ZVZ)

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: Similasan Corporation
Labeler Code: 59262
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: 07-08-2021 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.

Dry Eye Relief Trial Size 15x 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 Ingredient

Belladonna* 6X*containing 0.000002% alkaloids calculated as hyoscyamine.

Euphrasia officinalis (Eyebright) 6X

Mercurius sublimatus 15X

Purpose

Dryness, redness

Redness

Dryness, watering

Uses*

  • According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:dry eyeredness of eyes and lidsreflex watering secondary to dry eye

Warnings

  • For external use only.According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).Use only if single-use dropper is intact.To avoid contamination, do not touch the tip of the dropper to any surface. Do not reuse. Once opened, discard.Contact wearers: consult a physician prior to using.

If Pregnant, Trying To Get Pregnant Or Breast Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use:

If the solution changes color or becomes cloudy

Stop Use And Ask A Doctor If:

  • Symptoms worsen or persist for more than 72 hoursyou experience eye pain or changes in vision

Directions

  • For adults and children age 2 and over:twist flat end with ball to opensqueeze plastic dropper to release 2-3 drops into eye and discard applicatorapply as needed

Inactive Ingredients

Phosphate buffer, Purified water

* Please review the disclaimer below.