FDA Label for Optiq Balance

View Indications, Usage & Precautions

Optiq Balance Product Label

The following document was submitted to the FDA by the labeler of this product Optiq Eyecare Llc. 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



Drug Facts

Active IngredientsPurpose
Light mineral oil (0.6%)Emollient
Mineral oil (0.6%)Emollient


Uses



  • Temporary relief of burning and irritation due to dryness of the eye
  • Temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
  • As a protectant to prevent further irritation or to relieve dryness of the eye

Warnings



For external use only


Do Not Use



  • if emulsion changes color
  • if you are sensitive to any ingredient in this product

When Using This Product



  • Do not touch the tip of container to any surface to avoid contamination
  • Replace cap after each use

Otc - Stop Use



Stop use and ask a doctor ifyou experience any of the following:

  • Eye pain
  • Changes in vision
  • Continued redness or irritation of the eye
  • Condition worsens or persists for more than 72 hours

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • Shake well before use
  • Instill 1 to 2 drop(s) in the affected eye(s) as needed or as directed by your doctor
  • See side of carton for directions for use

Other Information



  • Temporarily blurred vision is typical upon application
  • Drops appear as a milky white emulsion
  • Store at 15-25°C (59-77°F)

Inactive Ingredients



Gellan Gum, Glyceryl Monostearate, Polysorbate 80, Hypromellose, Sodium Hyaluronate, Trehalose, Mannitol, Tromethamine and Purified Water.


Questions?



Call: 1-877-696-7848

[email protected]
www.optiqeyecare.com

Directions for Use:

1. Hold the bottle just below the cap and twist the cap to open.
2. Before first use, hold the bottle upside down and dispense one drop of product to discard.
3. Shake the bottle downward to remove residual product (see picture).

4. Place 1 or 2 drops as needed in the affected eye(s) and blink.
5. After use, shake the bottle downward to remove residual product that may be left on the tip (picture above).
6. Replace cap after use.

Tamper Evident

For your protection this bottle has a tamper evident ring around the bottom of the cap. Do not use if this ring is damaged or missing at the time of purchase. 

Marketed and Distributed by:
Optiq Eyecare
PO Box 32
Paramus, NJ 07652


Principal Display Panel



Optiq Eyecare

NDC: 85949-113-10

Optiq

RESTORE

ADVANCED LIPID COMPLEX

MGD RELIEF


* Please review the disclaimer below.