Optiq Balance
FDA Label NDC 85949-111

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Optiq Eyecare Llc for the product Optiq Balance (NDC 85949-111). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, uses, warnings, do not use, when using this product, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Drug Facts

Active IngredientsPurpose
Prolylene glycol (0.5%)Lubricant
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, Polyethylene Glycol 400, 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).

Use Diagram (Optiq Packaging R7 Balance Use Diagram)

Use Diagram (Optiq Packaging R7 Balance Use Diagram)

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.

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

Principal Display Panel

Optiq Eyecare

NDC: 85949-111-10

Optiq

Balance

Complete Relief from

DRY EYES

Carton Label (Optiq Packaging R7 Balance)

Carton Label (Optiq Packaging R7 Balance)

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