Stye Eye Relief
Conium Maculatum Flowering Top, Graphite And Sulfur
Similasan Ag
Human Otc Drug
NDC 53799-305Stye Eye Relief also known as Conium Maculatum Flowering Top, Graphite And Sulfur is a human otc drug labeled by 'Similasan Ag'. National Drug Code (NDC) number for Stye Eye Relief is 53799-305. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Stye Eye Relief drug includes Conium Maculatum Flowering Top - 6 [hp_X]/10mL Graphite - 12 [hp_X]/10mL Sulfur - 12 [hp_X]/10mL . The currest status of Stye Eye Relief drug is Active.
Drug Information:
| Drug NDC: | 53799-305 |
| 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: | Stye 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: | Conium Maculatum Flowering Top, Graphite And Sulfur |
| 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: | CONIUM MACULATUM FLOWERING TOP - 6 [hp_X]/10mL
GRAPHITE - 12 [hp_X]/10mL
SULFUR - 12 [hp_X]/10mL
|
| 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 Jan, 2005 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 2025 |
| 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: | Q28R5GF371
4QQN74LH4O
70FD1KFU70
|
| 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 |
|---|
| 53799-305-11 | 10 mL in 1 BOTTLE, DROPPER (53799-305-11) | 02 Jan, 2005 | 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. |
Purpose:
Purpose redness
Purpose eyelid redness
Purpose tearing, burning
Product Elements:
Stye eye relief conium maculatum flowering top, graphite and sulfur conium maculatum flowering top conium maculatum flowering top graphite graphite sulfur sulfur boric acid water silver sulfate sodium nitrate
Indications and Usage:
Uses: according to homeopathic principles, the active ingredients in this medication temporarily relieve minor symptoms such as: redness burning eyelid redness tearing
Warnings:
Warnings: the purpose of this product is to provide temporary relief of stye symptoms, and is not a cure for styes. for external use only. according to homeopathic principles, symptoms may temporarily worsen before improving (initial exacerbation of symptoms). to avoid contamination do not touch the tip of the container to any surface. to avoid contamination use within 30 days of opening. expiration date only refers to unopened bottle. â our drops will not harm contact lenses, however we recommend not wearing contacts while experiencing eye irritation. 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 if condition is accompanied by fever stop use and ask a doctor if: you experience eye pain or changes in vision symptoms worsen or persist for more than 72 hours the stye enl
Read more...arges the style opens, draining discharge or pus into the eye
Do Not Use:
Warnings: the purpose of this product is to provide temporary relief of stye symptoms, and is not a cure for styes. for external use only. according to homeopathic principles, symptoms may temporarily worsen before improving (initial exacerbation of symptoms). to avoid contamination do not touch the tip of the container to any surface. to avoid contamination use within 30 days of opening. expiration date only refers to unopened bottle. â our drops will not harm contact lenses, however we recommend not wearing contacts while experiencing eye irritation. 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 if condition is accompanied by fever stop use and ask a doctor if: you experience eye pain or changes in vision symptoms worsen or persist for more than 72 hours the stye enlarges the style opens, draining discharge or pus into the eye
Dosage and Administration:
Directions: for adults and children age 2 and over: remove tamper evident seal from neck of bottle twist cap off bottle donât squeeze bottle, squeeze plastic tip to release 1 to 2 drops into eye apply 3-4 times per day replace cap after use if desired, use with a warm, moistened washcloth placed directly on eyelid
Stop Use:
Stop use and ask a doctor if: you experience eye pain or changes in vision symptoms worsen or persist for more than 72 hours the stye enlarges the style opens, draining discharge or pus into the eye
Package Label Principal Display Panel:
Principal display panel similasan stye eye relief sterile eye drops 10 ml / 0.33 fl oz similasan stye eye relief sterile eye drops 10 ml / 0.33 fl oz similasan stye eye relief sterile eye drops 10 ml / 0.33 fl oz
Further Questions:
Questions? reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com. www.similasanusa.com