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Optiq Balance

OPTIQ RESTORE ADVANCED LIPID COMPLEX MGD RELIEF PRESERVATIVE FREE

Approved
Approval ID

e9fbc4b5-716a-4caa-9bab-b4a498181114

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 20, 2025

Manufacturers
FDA

Optiq Eyecare LLC

DUNS: 139782805

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Light Mineral Oil, Mineral Oil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85949-113
Application NumberM018
Product Classification
M
Marketing Category
C200263
G
Generic Name
Light Mineral Oil, Mineral Oil
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 20, 2025
FDA Product Classification

INGREDIENTS (11)

GELLAN GUMInactive
Code: 7593U09I4D
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE 2910 (4000 MPA.S)Inactive
Code: RN3152OP35
Classification: IACT
SODIUM HYALURONATEInactive
Code: YSE9PPT4TH
Classification: IACT
TREHALOSE DIHYDRATEInactive
Code: 7YIN7J07X4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LIGHT MINERAL OILActive
Quantity: 6 mg in 1 mL
Code: N6K5787QVP
Classification: ACTIB
MINERAL OILActive
Quantity: 6 mg in 1 mL
Code: T5L8T28FGP
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/20/2025

PRINCIPAL DISPLAY PANEL

Optiq Eyecare

NDC: 85949-113-10

Optiq

RESTORE

ADVANCED LIPID COMPLEX

MGD RELIEF

Carton label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/18/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/20/2025

Drug Facts

Active Ingredients

Purpose

Light mineral oil (0.6%)

Emollient

Mineral oil (0.6%)

Emollient

WARNINGS SECTION

LOINC: 34071-1Updated: 8/18/2025

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

Stop use and ask a doctor if****you 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

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/18/2025

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/18/2025

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 9/20/2025

Inactive Ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/20/2025

Questions?

Call: 1-877-696-7848

hello@optiqeyecare.com
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

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

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Optiq Balance - FDA Drug Approval Details