NDC 53799-302 Allergy Eye Relief

Apis Mellifera, Euphrasia Stricta And Schoenocaulon Officinale Seed

NDC Product Code 53799-302

NDC 53799-302-12

Package Description: .4 mL in 1 BOTTLE, DROPPER

NDC Product Information

Allergy Eye Relief with NDC 53799-302 is a a human over the counter drug product labeled by Similasan Ag. The generic name of Allergy Eye Relief is apis mellifera, euphrasia stricta and schoenocaulon officinale seed. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Similasan Ag

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.

Allergy 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.

  • APIS MELLIFERA 6 [hp_X]/.45mL
  • EUPHRASIA STRICTA 6 [hp_X]/.45mL
  • SCHOENOCAULON OFFICINALE SEED 6 [hp_X]/.45mL

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)
  • SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)

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: Similasan Ag
Labeler Code: 53799
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: 09-28-2020 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 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.

Allergy 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

Apis mellifica 6XEuphrasia officinalis (Eyebright) 6XSabadilla 6X

Purpose

Burning, itching, stingingredness, swelling, wateringwatering, redness of lids

Uses*

  • According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as: • itching • burning • excessive wateringredness of eyes and lids

Warnings

• For external use only.• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).• Use only if single-use dropper is intact.• To avoid contamination, do not touch the tip of the dropper to any surface. Do not reuse. Once opened, discard.• Contact lens wearers: consult a physician prior to using.

Keep Out Of Reach Of Children.

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

Do Not Use:

• if solution changes color or becomes cloudy

Stop Use And Ask A Doctor If:

• symptoms worsen or persist for more than 72 hours• you experience eye pain or changes in vision

Directions

For adults and children age 2 and over:• remove a single-use dropper• twist flat end with ball to remove• squeeze plastic dropper to release 2-3 drops into eye and discard applicator• apply as needed• use a new dropper for every application

Other Information

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients

Phosphate buffer, Purified water

Questions?

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com www.SimilasanUSA.com

* Please review the disclaimer below.