NDC 59262-369 Childrens Pink Eye Relief

Atropa Belladonna, Calcium Sulfide, Euphrasia Stricta And Platycladus Orientalis Leaf

NDC Product Code 59262-369

NDC Code: 59262-369

Proprietary Name: Childrens Pink 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: Atropa Belladonna, Calcium Sulfide, Euphrasia Stricta And Platycladus Orientalis Leaf 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

  • 59262 - Similasan Corporation
    • 59262-369 - Childrens Pink Eye Relief

NDC 59262-369-11

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

NDC Product Information

Childrens Pink Eye Relief with NDC 59262-369 is a a human over the counter drug product labeled by Similasan Corporation. The generic name of Childrens Pink Eye Relief is atropa belladonna, calcium sulfide, euphrasia stricta and platycladus orientalis leaf. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Similasan Corporation

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.

Childrens Pink 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.

  • ATROPA BELLADONNA 6 [hp_X]/10mL
  • EUPHRASIA STRICTA 6 [hp_X]/10mL
  • CALCIUM SULFIDE 12 [hp_X]/10mL
  • PLATYCLADUS ORIENTALIS LEAF 15 [hp_X]/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: Similasan Corporation
Labeler Code: 59262
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: 03-01-2019 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: 12-31-2019 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.

Childrens Pink 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

Belladonna 6X† Euphrasia officinalis (Eyebright) 6X Hepar sulphuris 12X Thuja 15X

Purpose

Dryness, redness, burningredness, burning, wateringsensation of grittiness, stingingirritation

Uses*

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:• redness of the eyes• irritation, dryness, and burning• sensation of grittiness• excessive watering (clear)

Warnings

• For external use only.• Children under 2 years of age should be seen by a physician.• 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 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

Stop Use And Ask A Doctor If:

• the child experiences eye pain or changes in vision• symptoms worsen or persist for more than 72 hours

Directions

For children ages 2 and over:• remove tamper-evident seal from neck of bottle• twist cap off bottle• DON'T squeeze bottle, squeeze plastic tip to release 1 to 2 drops into eye• apply as needed• replace 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†containing 0.000002% alkaloids calculated as hyoscyamine

* Please review the disclaimer below.

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