Dry Eye Relief

Atropa Belladonna And Euphrasia Stricta And Mercuric Chloride

Similasan Ag
Human Otc Drug
NDC 53799-300

Dry Eye Relief also known as Atropa Belladonna And Euphrasia Stricta And Mercuric Chloride is a human otc drug labeled by 'Similasan Ag'. National Drug Code (NDC) number for Dry Eye Relief is 53799-300. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Dry Eye Relief drug includes Atropa Belladonna - 6 [hp_X]/.4mL Euphrasia Stricta - 6 [hp_X]/.4mL Mercuric Chloride - 15 [hp_X]/.4mL . The currest status of Dry Eye Relief drug is Active.

Drug Information:

Drug NDC:	53799-300
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Dry Eye Relief
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Atropa Belladonna And Euphrasia Stricta And Mercuric Chloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Similasan Ag
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Solution/ Drops
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ATROPA BELLADONNA - 6 [hp_X]/.4mL EUPHRASIA STRICTA - 6 [hp_X]/.4mL MERCURIC CHLORIDE - 15 [hp_X]/.4mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	OPHTHALMIC
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	02 Oct, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	05 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2024
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Similasan AG
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	WQZ3G9PF0H C9642I91WL 53GH7MZT1R
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
53799-300-12	20 VIAL, SINGLE-USE in 1 CARTON (53799-300-12) / .4 mL in 1 VIAL, SINGLE-USE	02 Oct, 2020	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Dry Eye Relief

Atropa Belladonna And Euphrasia Stricta And Mercuric Chloride

Solution/ Drops
Similasan AG
NDC: 53799-300

Dry Eye Relief

Atropa Belladonna And Euphrasia Stricta And Mercuric Chloride

Solution/ Drops
Similasan Corporation
NDC: 59262-375

Purpose:

Purpose dryness, redness redness dryness, watering

Product Elements:

Dry eye relief atropa belladonna and euphrasia stricta and mercuric chloride atropa belladonna atropa belladonna euphrasia stricta euphrasia stricta mercuric chloride mercuric cation sodium phosphate, monobasic, dihydrate sodium phosphate, dibasic, anhydrous water

Indications and Usage:

Uses* according to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as: â¢ dry eye â¢ redness of eyes and lids â¢ reflex watering secondary to dry eye

Warnings:

Warnings â¢ for external use only. â¢ according to homeopathic principles, symptoms may temporarily worsen before improving (initial exacerbation of symptoms). â¢ use only if single-use dropper is intact. â¢ to avoid contamination, do not touch the tip of the dropper to any surface. do not reuse. once opened, discard. â¢ contact lens 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: â¢ if solution changes color or becomes cloudy stop use and ask a doctor if: â¢ symptoms worsen or persist for more than 72 hours â¢ you experience eye pain or changes in vision

Do Not Use:

Dosage and Administration:

Directions for adults and children age 2 and over: â¢ remove a single-use dropper â¢ twist flat end with ball to remove â¢ squeeze plastic dropper to release 2-3 drops into eye and discard applicator â¢ apply as needed â¢ use a new dropper for every application

Stop Use:

Stop use and ask a doctor if: â¢ symptoms worsen or persist for more than 72 hours â¢ you experience eye pain or changes in vision

Package Label Principal Display Panel:

Principal display panel dry eye relief 0.4 ml/0.014 fl oz each dry eye relief 0.4 ml/0.014 fl oz each

Further Questions:

Questions? reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com www.similasanusa.com

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.