Opticview
Chamomilla
Pharmadel Llc
Human Otc Drug
NDC 55758-329Opticview also known as Chamomilla is a human otc drug labeled by 'Pharmadel Llc'. National Drug Code (NDC) number for Opticview is 55758-329. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Opticview drug includes Matricaria Chamomilla - 3 [hp_X]/15mL . The currest status of Opticview drug is Active.
Drug Information:
| Drug NDC: | 55758-329 |
| 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: | Opticview |
| 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: | Chamomilla |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Pharmadel Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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: | MATRICARIA CHAMOMILLA - 3 [hp_X]/15mL
|
| 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: | 15 Mar, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 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, 2023 |
| 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: | Pharmadel LLC
|
| 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: | G0R4UBI2ZZ
|
| 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 |
|---|
| 55758-329-15 | 1 BOTTLE, DROPPER in 1 BOX (55758-329-15) / 15 mL in 1 BOTTLE, DROPPER | 15 Mar, 2022 | 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:
Active ingredient** purposes* chamomilla vulgaris 3x (hpus).............. dryness, irritation the letters âhpusâ indicate that this ingredient is officially included in the homeopathic pharmacopeia of the united states.
Product Elements:
Opticview chamomilla matricaria chamomilla matricaria recutita potassium phosphate, unspecified form sodium chloride water benzalkonium chloride
Indications and Usage:
Uses* as a lubricant to prevent further irritation or to relieve dryness of the eye.
Warnings:
Warnings for ophthalmic use only. do not use if solution changes color or becomes cloudy. discard product and replace with a new bottle. stop use and ask a doctor if you experience eye pain changes in vision redness or irritation of the ey conditionspersist or worsen for more than 72 hours keep out of reach of children.
Do Not Use:
Warnings for ophthalmic use only. do not use if solution changes color or becomes cloudy. discard product and replace with a new bottle. stop use and ask a doctor if you experience eye pain changes in vision redness or irritation of the ey conditionspersist or worsen for more than 72 hours keep out of reach of children.
Dosage and Administration:
Directions pull down the lower lid of the affected eye apply 2 drops to the inside of the eyelid as needed to avoid contamination, do not touch the dropper tip to any surface. replace cap after using use within 30 days of opening
Stop Use:
Stop use and ask a doctor if you experience eye pain changes in vision redness or irritation of the ey conditionspersist or worsen for more than 72 hours
Package Label Principal Display Panel:
Principal display panel opticview pdp