NDC 17312-002 Blur Relief

Jacobaea Maritima, Calcium Fluoride, Conium Maculatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, Sodium Chloride, Ruta Graveolens Flowering Top

NDC Product Code 17312-002

NDC CODE: 17312-002

Proprietary Name: Blur Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Jacobaea Maritima, Calcium Fluoride, Conium Maculatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, Sodium Chloride, Ruta Graveolens Flowering Top What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

NDC 17312-002-11

Package Description: 1 BOTTLE, DROPPER in 1 PACKAGE > 15 mL in 1 BOTTLE, DROPPER

NDC Product Information

Blur Relief with NDC 17312-002 is a a human over the counter drug product labeled by Trp Company. The generic name of Blur Relief is jacobaea maritima, calcium fluoride, conium maculatum flowering top, euphrasia stricta, gelsemium sempervirens root, sodium chloride, ruta graveolens flowering top. The product's dosage form is liquid and is administered via intraocular form.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Blur 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.


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)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intraocular - Administration within the eye.

Product Labeler Information

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

Labeler Name: Trp Company
Labeler Code: 17312
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: 06-01-2006 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: 12-31-2022 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.

Blur 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 IngredientsPurposeCineraria Maritima HPUS 5XCloudy VisionCalcarea fluorica HPUS 13XOpacitiesConium Maculatum HPUS 6xPoor Night VisionEuphrasia (Eyebright) HPUS 6xDryness, RednessGelsemium HPUS 6xBlurry visionNatrum Muriaticum HPUS 6xDifficulty readingRuta Graveolens HPUS 6xTired EyesThe letters HPUS indicate that the components of this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Indications & Usage

Uses:*According to homeopathic indications these ingredients provide temporary relief from symptoms such as:

• Blurry Vision

• Dry, Red & Tired Eyes

• Poor Night Vision (Glare)

• Difficulty reading after serious causes have been ruled out by a physician.

*These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings

  • Warnings:A PHYSICIAN SHOULD ALWAYS BE CONSULTED TO RULE OUT SERIOUS CAUSES. For External Use Only. This product is intended to complement not replace, standard medical treatment.Initial worsening of symptoms may occur.Physician should always be consulted to rule out serious conditions.

  • Contact lens wearers consult physician prior to using.To avoid contamination - do not touch tip to any surface.Replace cap after every use.Use within 30 days of opening.EXPIRATION DATE ONLY REFERS TO THE UNOPENED BOTTLE.The use of this container by more than one person may spread infection.

Otc - Pregnancy Or Breast Feeding

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

Do Not Use:

• If solution changes color or becomes cloudy.
• If you frequently contract infections that do not clear up easily.
• If you experience eye pain or changes in vision.

Stop Use And Ask A Doctor If:

• You experience eye pain, changes in vision, continued redness or irritation of the eye.
• The condition worsens.
• The condition persists for more than 72 hours.

Otc - Keep Out Of Reach Of Children

• Keep out of reach of children.

Other

• In case of accidental ingestion, get medical help or contact a
Poison Control Center right away.

  • Other information:There are no known contraindications
  • Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the
  • United States and are therefore non-toxic with no known side effects.
  • Blur Relief Homeopathic Sterile Eye Drops are homeopathic dilutions:
  • See www.thereliefproducts.com for details.
  • Store at room temperature 15° to 30° C (59° to 86° F).Keep bottle tightly closed

Dosage & Administration

Directions:• Suitable for adults and children ages 2 and over. • Children under the age of 2: Consult a physician before use. • Squeeze 1-3 drops in the eye. • Use several times per day as needed. • Use within 30 days of opening. • Expiration date only refers to unopened bottle. • Homeopathic remedies may not be effective for everyone. • May take up to 60 days to see results.

Inactive Ingredient

Inactive ingredients:
Benzalkonium Chloride,
Purified Water,
Sodium Chloride,
Sodium Phosphate Dibasic,
Sodium Phosphate Monobasic

* Please review the disclaimer below.