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  5. Label Information: Optical Advanced Eye

FDA Label for Optical Advanced Eye

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - WHEN USING
    5. OTC - STOP USE
    6. OTC - PREGNANCY OR BREAST FEEDING
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. INDICATIONS & USAGE
    9. STORAGE AND HANDLING
    10. INACTIVE INGREDIENT
    11. DOSAGE & ADMINISTRATION
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Optical Advanced Eye Product Label

The following document was submitted to the FDA by the labeler of this product Televisa Consumer Products Usa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredients                                                        Purpose

Dextran 70 0.1%..........................................................Lubricant

Polyethylene Glycol 400 1% ........................................Lubricant

Povidone 1% ..............................................................Lubricant

Tetrahydrozoline HCL 0.05% .......................................Redness reliever


Otc - Purpose



Uses

  • for the relief of redness of the eyes due to minor eye irritations

Warnings



Ask a doctor before use if you have narrow angle glaucoma


Otc - When Using



When using this product

  • pupils may become enlarged temporarily
  • overuse may cause more eye redness
  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Otc - Stop Use



Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens or lasts more than 72 hours

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep out of the reach of children.

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


Indications & Usage



Directions

  • put 1 to 2 drops in the affected eye(s) up to 4 times daily
  • children under 6 years of age: ask a doctor

Storage And Handling



Other information

  • some users may experience a brief tingling sensation
  • store at 15o to 25oC (59o to 77oF)

Inactive Ingredient



Inactive ingredients: benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, and sodium borate


Dosage & Administration



DISTRIBUTED BY:

TELEVISA CONSUMER PRODUCTS USA, LLC

4550 POST OAK PLACE SUITE 326

HOUSTON, TX 77027

MADE IN KOREA


Package Label.Principal Display Panel



image of carton label - OpticalAdvanced

image of carton label - OpticalAdvanced


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