NDC 53799-301 Allergy Eye Relief

Apis Mellifera, Euphrasia Stricta, Schoenocaulon Officinale Seed

NDC Product Code 53799-301

NDC 53799-301-11

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

NDC Product Information

Allergy Eye Relief with NDC 53799-301 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, 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.

  • BORIC ACID (UNII: R57ZHV85D4)
  • 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: 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: 04-13-2015 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.

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 Ingredient

Apis mellifica 6X

Euphrasia officinalis (Eyebright) 6X

Sabadilla 6X

Purpose

Burning, itching, stinging

Redness, swelling, watering

Watering, redness of lids

Uses:

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

Warnings:

  • For external use only.According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).Replace cap tightly after every use.To avoid contamination, do not touch the plastic tip 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.

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

Stop Use And Ask A Doctor If:

  • Symptoms worsen or persist for more than 72 hoursyou experience eye pain or changes in vision

Directions:

  • For adults and children age 2 and over:remove tamper-evident seal from neck of bottletwist cap off bottleDON’T squeeze bottle, squeeze plastic tip to release 2-3 drops into eyeapply as neededreplace cap after use

Other Information:

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients:

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

Questions?

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

* Please review the disclaimer below.