NDC 59262-377 Pink Eye Nighttime

Belladonna, Euphrasia Officinalis, Hepar Sulphuris

NDC Product Code 59262-377

NDC 59262-377-11

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

NDC Product Information

Pink Eye Nighttime with NDC 59262-377 is a a human over the counter drug product labeled by Similasan Corporation. The generic name of Pink Eye Nighttime is belladonna, euphrasia officinalis, hepar sulphuris. The product's dosage form is gel and is administered via ophthalmic form.

Labeler Name: Similasan Corporation

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Pink Eye Nighttime 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

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)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • 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.
  • 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: 11-09-2020 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.

Pink Eye Nighttime 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††containing 0.000002% alkaloids calculated as hyoscyamine

Euphrasia officinalis (Eyebright) 6X

Hepar sulphuris 12X

Purpose

Dryness, redness, burning, sensation of grittiness

Watery discharge

Redness, stinging

Uses*

According to homeopathic principles, the active ingredients in this product temporarily relieve minor eye symptoms:• excessive watery (clear) discharge• sensation of grittiness• redness and burning

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.• Replace cap tightly after every use.• Contact wearers: consult 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:

• you experience eye pain or changes in vision• symptoms worsen or persist for more than 72 hours• you might have a serious underlying medical cause for an infection

Directions

For adults and 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 1-2 drops into eye• apply as needed• replace cap after use

Other Information

• Active ingredients are manufactured according to homeopathic principles.• Store below 86°F

Inactive Ingredients

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

Questions?

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com.www.SimilasanUSA.comFor your protection do not use if tamper evident seal around neck of bottle is missing or broken.*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

* Please review the disclaimer below.