NDC 57619-402 Thrive

Chamomile

NDC Product Code 57619-402

NDC 57619-402-01

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 15 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Thrive with NDC 57619-402 is a a human over the counter drug product labeled by Laboratorios Sophia, S.a. De C.v.. The generic name of Thrive is chamomile. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Laboratorios Sophia, S.a. De C.v.

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.

Thrive 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.

  • MATRICARIA CHAMOMILLA 3 [hp_X]/mL

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.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

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.
  • 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: Laboratorios Sophia, S.a. De C.v.
Labeler Code: 57619
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: 11-12-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Thrive Product Label Images

Thrive 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

Other

Drug Facts

Manufactured by:LABORATORIOS SOPHIA, S.A. DE C.V.Av. Paseo del Norte No. 5255Guadelajara, Technology ParkZapopan, Jalisco, Mexico C.P. 45010Distributed by:LABS SOPHIA USA, INC.12941 North Freeway Houston, Suite 225Houston, Texas, USA 77060MADE IN MEXICO

Otc - Active Ingredient

Active ingredientChamomile (Matricaria chamomilla L.) 3X HPUS"HPUS" indicates that this ingredient is officially monographed in the Homeopathic Pharmacopoeia of the United States.

Otc - Purpose

PurposeEye moisturizer

Indications & Usage

Useto refresh and replenish moisture to the eyes.

Warnings

WarningsFor external use only

Otc - Do Not Use

Do not use if solution changes color or becomes cloudy.

Otc - When Using

  • When using this productdo not touch tip of container to any surface to avoid contaminationreplace cap after using

Otc - Stop Use

  • Stop use and ask a doctor ifyou experience eye pain, changes in vision, continued redness or irritation of the eyecondition worsens or persists for more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

DirectionsPut 2 drops into each eye as needed

Storage And Handling

  • Other informationStore at room temperaturedo not use if imprinted seal around cap is broken or missing.

Inactive Ingredient

Inactive ingredients Benzalkonium chloride (as preservative), purified water, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate

Otc - Questions

Questions?Call
1-866-282-8871www.sophia.com.mx

* Please review the disclaimer below.