Family Care Ultra Lubricant Eye Drops 588 (nbe Systane Ultra)

Family Care Ultra Lubricant Eye Drops 588 (nbe Systane Ultra)
SPL v2
SPL
SPL Set ID 1e2da97c-68a3-9a70-e063-6394a90a4fd4
Route
OPHTHALMIC
Published
Effective Date 2024-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 400 (4 mg) Propylene Glycol (3 mg)
Inactive Ingredients
Hypromellose, Unspecified Hydrochloric Acid Water Boric Acid Benzalkonium Chloride Potassium Chloride Sodium Chloride Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-22
Description

Drug Facts Active ingredients Purpose Polyethylene Glycol 400 0.4%....................... Eye lubricant Propylene Glycol 0.3%....................................Eye lubricant

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Directions

  • shake well before using
  • instill 1 or 2 drops in the affected eye(s) as needed
  • children under 6 years of age: ask a doctor
Dosage and Administration

Distributed by:

United Exchange Corp,

Cypress, CA 90630 USA

1-888-645-8204

Made in South Korea

Description

Drug Facts Active ingredients Purpose Polyethylene Glycol 400 0.4%....................... Eye lubricant Propylene Glycol 0.3%....................................Eye lubricant

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if

  • you experience eye pain and/or vision change
  • you continue to have eye redness and/or irritation
  • irritation, burning persists or worsens for more than 72 hours
Section 50567-7

When using this product

  • remove contact lenses before use
  • replace cap after each use
  • do not touch tip of bottle to any surface to avoid contamination
Section 50570-1

Do not use

  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient is this product
Section 51727-6

Inactive ingredients

benzalkonium chloride, boric acid, hypromellose, hydrochloric acid, potassium chloride, purified water, sodium chloride, sodium hydroxide

Section 51945-4

Section 53414-9

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

Section 55105-1

Uses

  • for the temporary relief of burning and irritation due to:
  • dryness of the eyes
  • exposure to wind or sun
Section 55106-9

Drug Facts

Active ingredients Purpose

Polyethylene Glycol 400 0.4%....................... Eye lubricant

Propylene Glycol 0.3%....................................Eye lubricant

Structured Label Content

Indications and Usage (34067-9)

Directions

  • shake well before using
  • instill 1 or 2 drops in the affected eye(s) as needed
  • children under 6 years of age: ask a doctor
Dosage and Administration (34068-7)

Distributed by:

United Exchange Corp,

Cypress, CA 90630 USA

1-888-645-8204

Made in South Korea

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • you experience eye pain and/or vision change
  • you continue to have eye redness and/or irritation
  • irritation, burning persists or worsens for more than 72 hours
Section 50567-7 (50567-7)

When using this product

  • remove contact lenses before use
  • replace cap after each use
  • do not touch tip of bottle to any surface to avoid contamination
Section 50570-1 (50570-1)

Do not use

  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient is this product
Section 51727-6 (51727-6)

Inactive ingredients

benzalkonium chloride, boric acid, hypromellose, hydrochloric acid, potassium chloride, purified water, sodium chloride, sodium hydroxide

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses

  • for the temporary relief of burning and irritation due to:
  • dryness of the eyes
  • exposure to wind or sun
Section 55106-9 (55106-9)

Drug Facts

Active ingredients Purpose

Polyethylene Glycol 400 0.4%....................... Eye lubricant

Propylene Glycol 0.3%....................................Eye lubricant

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:20.574828 · Updated: 2026-03-14T23:13:21.652895