NDC 0363-9051 Walgreens Stye Eye Relief

Conium Maculatum, Graphites, Sulphur

NDC Product Code 0363-9051

NDC Code: 0363-9051

Proprietary Name: Walgreens Stye Eye 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: Conium Maculatum, Graphites, Sulphur 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

  • 0363 - Walgreen Company
    • 0363-9051 - Walgreens Stye Eye Relief

NDC 0363-9051-11

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 10 mL in 1 BOTTLE, DROPPER

NDC Product Information

Walgreens Stye Eye Relief with NDC 0363-9051 is a a human over the counter drug product labeled by Walgreen Company. The generic name of Walgreens Stye Eye Relief is conium maculatum, graphites, sulphur. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Walgreen Company

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.

Walgreens Stye Eye 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.

  • CONIUM MACULATUM FLOWERING TOP 6 [hp_C]/10mL
  • GRAPHITE 12 [hp_C]/10mL
  • SULFUR 12 [hp_C]/10mL

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.

  • WATER (UNII: 059QF0KO0R)
  • SILVER SULFATE (UNII: 8QG6HV4ZPO)
  • SODIUM NITRATE (UNII: 8M4L3H2ZVZ)

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: Walgreen Company
Labeler Code: 0363
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: 06-01-2019 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.

Walgreens Stye Eye 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

Active Ingredients

Conium maculatum 6XGraphites 12X Sulphur 12X

Purpose

Rednesseyelid rednesstearing, burning

Uses*

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:• redness • burning • eyelid redness • tearing

Warnings

•The purpose of this product is to provide temporary relief of stye symptoms, and is not a cure for styes.• For external use only.• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).• To avoid contamination do not touch the tip of the bottle to any surface.• To avoid contamination use within 30 days of opening. Expiration date only refers to unopened bottle.• Contact wearers: consult a physician prior to using.

If Pregnant, Trying To Get Pregnant Or Breast Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use:

• if the solution changes color or becomes cloudy• if condition is accompanied by fever

Stop Use And Ask A Doctor If:

• you experience eye pain or changes in vision• symptoms worsen or persist for more than 72 hours• the stye enlarges• the stye opens, draining discharge or pus into the eye

Directions

For adults and children age2 and over:• remove tamper evident seal from neck of bottle• twist cap off bottle• DON'T squeeze bottle, squeeze plastic tip to release 2 to 3 drops into eye• apply 3-4 times per day• replace cap after use• if desired, use with a warm, moistened washcloth placed directly on eyelid

Other Information

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients

Borate buffer, Purified water, Silver sulfate (as preservative), Sodium nitrate

Questions?

1-800-925-4733

* Please review the disclaimer below.

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