Manzanilla Sophia
Chamomile (matricaria Chamomilla L.)
Laboratorios Sophia, S.a. De C.v.
Human Otc Drug
NDC 57619-400Manzanilla Sophia also known as Chamomile (matricaria Chamomilla L.) is a human otc drug labeled by 'Laboratorios Sophia, S.a. De C.v.'. National Drug Code (NDC) number for Manzanilla Sophia is 57619-400. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Manzanilla Sophia drug includes Matricaria Recutita - 3 [hp_X]/mL . The currest status of Manzanilla Sophia drug is Active.
Drug Information:
| Drug NDC: | 57619-400 |
| 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: | Manzanilla Sophia |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Manzanilla |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Sophia |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Chamomile (matricaria Chamomilla L.) |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Laboratorios Sophia, S.a. De C.v. |
| 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: | MATRICARIA RECUTITA - 3 [hp_X]/mL
|
| 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: | 12 Apr, 2010 |
| 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, 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: | LABORATORIOS SOPHIA, S.A. DE C.V.
|
| 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. |
| UPC: | 0736085408485
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 57619-400-01 | 1 BOTTLE, PLASTIC in 1 PACKAGE (57619-400-01) / 15 mL in 1 BOTTLE, PLASTIC | 12 Apr, 2010 | 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 eye moisturizer
Product Elements:
Manzanilla sophia chamomile (matricaria chamomilla l.) benzalkonium chloride water sodium chloride sodium phosphate, monobasic, monohydrate sodium phosphate, dibasic, anhydrous matricaria recutita matricaria recutita
Indications and Usage:
Use* to refresh and replenish moisture to eyes.
Warnings:
Warnings for external use only do not use if solution changes color or becomes cloudy when using this product do not touch tip of container to any surface to avoid contamination replace cap after using stop use and ask a doctor if you feel eye pain changes in vision occur redness or irritation of the eye lasts condition worsens or lasts more than 72 hours keep out of reach of children. if swallowed, get medical help or contact a poison control center right away
Do Not Use:
Warnings for external use only do not use if solution changes color or becomes cloudy when using this product do not touch tip of container to any surface to avoid contamination replace cap after using stop use and ask a doctor if you feel eye pain changes in vision occur redness or irritation of the eye lasts condition worsens or lasts more than 72 hours keep out of reach of children. if swallowed, get medical help or contact a poison control center right away
When Using:
When using this product do not touch tip of container to any surface to avoid contamination replace cap after using
Dosage and Administration:
Directions put 2 drops into each eye as needed
Stop Use:
Stop use and ask a doctor if you feel eye pain changes in vision occur redness or irritation of the eye lasts condition worsens or lasts more than 72 hours
Package Label Principal Display Panel:
Homeopathic manzanilla sophia⢠chamomile herbal eye drops refresh your eyes cleanses soothes 0.5 fl oz (15 ml) sterile manzanilla sophia 11-2021
Further Questions:
Questions? 1-866-202-8871 www.manzanillasophia.com