NDC 0220-9277 Optique 1

Jacobaea Maritima, Euphrasia Stricta, Calendula Officinalis Flowering Top, Potassium Chloride, Silicon Dioxide, Calcium Fluoride, Magnesium Carbonate

NDC Product Code 0220-9277

NDC CODE: 0220-9277

Proprietary Name: Optique 1 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: Jacobaea Maritima, Euphrasia Stricta, Calendula Officinalis Flowering Top, Potassium Chloride, Silicon Dioxide, Calcium Fluoride, Magnesium Carbonate 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is a mineral supplement used to treat or prevent low amounts of potassium in the blood. A normal level of potassium in the blood is important. Potassium helps your cells, kidneys, heart, muscles, and nerves work properly. Most people get enough potassium by eating a well-balanced diet. Some conditions that can lower your body's potassium level include severe prolonged diarrhea and vomiting, hormone problems such as hyperaldosteronism, or treatment with water pills/diuretics.

NDC Code Structure

NDC 0220-9277-72

Package Description: 30 mL in 1 BOX

NDC 0220-9277-76

Package Description: 10 mL in 1 BOX

NDC Product Information

Optique 1 with NDC 0220-9277 is a a human over the counter drug product labeled by Laboratoires Boiron. The generic name of Optique 1 is jacobaea maritima, euphrasia stricta, calendula officinalis flowering top, potassium chloride, silicon dioxide, calcium fluoride, magnesium carbonate. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Laboratoires Boiron

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Optique 1 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.

  • JACOBAEA MARITIMA 6 [hp_C]/mL
  • EUPHRASIA STRICTA 9 [hp_C]/mL
  • CALENDULA OFFICINALIS FLOWERING TOP 4 [hp_X]/mL
  • POTASSIUM CHLORIDE 10 [hp_X]/mL
  • SILICON DIOXIDE 10 [hp_C]/mL
  • CALCIUM FLUORIDE 10 [hp_X]/mL
  • MAGNESIUM CARBONATE 10 [hp_X]/mL

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 CHLORIDE (UNII: 451W47IQ8X)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Laboratoires Boiron
Labeler Code: 0220
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: 07-17-1995 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.

Optique 1 Product Label Images

Optique 1 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

Otc - Active Ingredient

Cineraria maritima 6C, Euphrasia officinalis 4X, Calendula officinalis 4X, Kali Muriaticum 10X, Calcarea fluorica 10X, Magnesia carbonica 10X, Silicea 10X

Indications & Usage

Temporarily relieves minor eye irritation due to fatigue or airborne irritants such as ragweed, other pollens and dust.


Soothes red, dry, itchy, burning or tired eyes.

Otc - Do Not Use

Do not use if glued carton en flaps are open or if the single-use dose container is not intact.


Do not use if solutions changes color or becomes cloudy.

Dosage & Administration

Snap off one single-use dose. Twist to open. Instill 1 to 2 drops, or more if necessary in affected eye(s). Repeat 2 to 6 times a day, as needed, or as directed by a doctor.

Inactive Ingredient

Purified water, sodium chloride 0.9%

How Supplied

Sterile single-use liquid doses.013 fl oz each

Otc - Purpose

Cineraria maritima 6C soothes red and irritated eyesEuphrasia officinalis 4X relieves burning, irritated eyesCalendula officinalis 4X relieves eye dryness associated with smoke or other airborne irritantsKali Muriaticum 10X alleviates gritty sensation (feeling of sand in the eye)Calcarea fluorica 10X relieves eye strain and fatigue characterized by flickering lightMagnesia carbonica 10X relieves sharp, flashing eye painSilicea 10X relieves tired eyes

Storage And Handling

Store at 68-77


O F (20-25


O C)

Otc - Questions

Questions, Comments?www.boironusa.cominfo@boironusa.com1-800-BOIRON-1 (1-800-264-7661)


Boiron Information Center


6 Campus Boulevard


Newtown Square, PA 19073-3267

Otc - Stop Use

Stop use and ask doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - When Using

N/A

Drug Interactions

Safe - soothing - preservative free - no side effects - no drug interactions - works naturally with your body

Warnings

To avoid contamination:


Do not touch tip of container to any surface.


Do not the eye with the tip of the container.


Do not reuse


Once opened, discard container after each use.

* Please review the disclaimer below.