Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID f29c792c-6cb2-449f-b97d-6304a58dec2a
Route
OPHTHALMIC
Published
Effective Date 2024-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyvinyl Alcohol (5 mg) Povidone (6 mg)
Inactive Ingredients
Benzalkonium Chloride Dextrose, Unspecified Form Edetate Disodium Potassium Chloride Water Sodium Bicarbonate Sodium Chloride Sodium Citrate, Unspecified Form Sodium Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-07-22
Description

Uses • temporary relieves burning and irritations due to dryness of the eye(s) • protects against further irritation

Dosage and Administration

• Instill 1 or 2 drops in the affected eye(s) as needed.

Medication Information

Warnings and Precautions

Warnings

For external use only.  Do not use if solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product.

Indications and Usage

Directions

  • •
    Instill 1 or 2 drops in the affected eye(s) as needed.
  • •
    Store at 15-25C (59-77F).
  • •
    Children under 6 years of age: Ask a doctor

Dosage and Administration
  • •
    Instill 1 or 2 drops in the affected eye(s) as needed.
Description

Uses • temporary relieves burning and irritations due to dryness of the eye(s) • protects against further irritation

Section 50565-1

Keep out of the reach of children.

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

Section 50566-9

Stop use and ask a doctor if

  • •
    you feel eye pain

  • •
    changes in vision occur
  • •
    redness or irritation of the eye gets worse or lasts more than 72 hours

Section 50567-7

When using this product

  • •
    remove contact lenses before using
  • •
    do not touch tip of container to any surface to avoid contamination
  • •
    replace cap after each use

Section 51727-6

Inactive Ingredients: Benzalkonium Chloride, Dextrose, Disodium Edetate, Potassium Chloride, Purified Water, Sodium Bicarbonate, Sodium Chloride, Sodium Citrate, Sodium Phosphate (Mono- and Dibasic)

Section 51945-4

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

Section 53414-9

If pregnant or breast-feeding,

ask a health professional before use.

Section 55105-1

Uses

  • •
    temporary relieves burning and irritations due to dryness of the eye(s)
  • •
    protects against further irritation

Active Ingredient

Each mL contains: Polyvinyl Alcohol 5mg/ml and Povidone 6mg/ml - lubricant

Structured Label Content

Indications and Usage (34067-9)

Directions

  • •
    Instill 1 or 2 drops in the affected eye(s) as needed.
  • •
    Store at 15-25C (59-77F).
  • •
    Children under 6 years of age: Ask a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only.  Do not use if solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product.

Section 50565-1 (50565-1)

Keep out of the reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • •
    you feel eye pain

  • •
    changes in vision occur
  • •
    redness or irritation of the eye gets worse or lasts more than 72 hours

Section 50567-7 (50567-7)

When using this product

  • •
    remove contact lenses before using
  • •
    do not touch tip of container to any surface to avoid contamination
  • •
    replace cap after each use

Section 51727-6 (51727-6)

Inactive Ingredients: Benzalkonium Chloride, Dextrose, Disodium Edetate, Potassium Chloride, Purified Water, Sodium Bicarbonate, Sodium Chloride, Sodium Citrate, Sodium Phosphate (Mono- and Dibasic)

Section 51945-4 (51945-4)

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

Section 53414-9 (53414-9)

If pregnant or breast-feeding,

ask a health professional before use.

Section 55105-1 (55105-1)

Uses

  • •
    temporary relieves burning and irritations due to dryness of the eye(s)
  • •
    protects against further irritation

Active Ingredient

Each mL contains: Polyvinyl Alcohol 5mg/ml and Povidone 6mg/ml - lubricant

Dosage and Administration
  • •
    Instill 1 or 2 drops in the affected eye(s) as needed.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:47.653527 · Updated: 2026-03-14T23:02:32.213463