NDC 55910-641 Dg Health Sterile Redness Relief

Tetrahydrozoline Hydrochloride

NDC Product Code 55910-641

NDC 55910-641-15

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

NDC Product Information

Dg Health Sterile Redness Relief with NDC 55910-641 is a a human over the counter drug product labeled by Dolgencorp Inc. The generic name of Dg Health Sterile Redness Relief is tetrahydrozoline hydrochloride. The product's dosage form is solution and is administered via ophthalmic form.

Labeler Name: Dolgencorp Inc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Dg Health Sterile Redness Relief 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.

  • TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/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)
  • BORIC ACID (UNII: R57ZHV85D4)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)

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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Dolgencorp Inc
Labeler Code: 55910
FDA Application Number: part349 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 11-25-2014 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: 12-31-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Tetrahydrozoline Ophthalmic

Tetrahydrozoline Ophthalmic is pronounced as (tet ra hye droz' a leen)

Why is tetrahydrozoline ophthalmic medication prescribed?
Ophthalmic tetrahydrozoline is used to relieve minor eye irritation and redness caused by colds, pollen, and swimming....
[Read More]

* Please review the disclaimer below.

Dg Health Sterile Redness Relief Product Label Images

Dg Health Sterile Redness Relief 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

Otc - Active Ingredient

Active ingredient                                                     PurposeTetrahydrozoline HCL 0.05%.................................. Redness reliever

Otc - Purpose

  • Usesfor the relief of redness of the eyes due to minor eye irritations

Warnings

Ask a doctor before use if you have narrow angle glaucoma

Otc - When Using

  • When using this productpupils may become enlarged temporarilyoveruse may cause more eye rednessremove contact lenses before using do not use if this solution changes color or becomes cloudyto avoid contamination, do not touch tip of container to any surfacereplace cap after each use

Otc - Stop Use

  • Stop use and ask a doctor ifyou feel eye painchanges in vision occurredness or irritation of the eye lastscondition worsens or lasts more than 72 hours

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

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.

Indications & Usage

  • Directionsto open bottle, push cap down and twist counter-clockwise. To close bottle, twist clockwise until it stops turning.put 1 or 2 drops in the affected eye(s) up to 4 times daily.children under 6 years of age: ask a doctor

Safe Handling Warning

  • Other informationsome users may experience a brief tingling sensationStore at 15
  • O-25
  • OC (59
  • O-77
  • OF)

Inactive Ingredient

Inactive ingredients:Benzalkonium chloride, Boric acid, Edetate disodium, Purified water, Sodium chloride, and Sodium borate

Dosage & Administration

DISTRIBUTED BY:DOLGENCORP, LLC100 MISSION RIDGEGOODLETTSVILLE, TN 37072MADE IN KOREA

* Please review the disclaimer below.