Qc Original Lubricant Eye Drops 0.5fl.oz (nbe Systane Original) 99929 (prop Gly)

Qc Original Lubricant Eye Drops 0.5fl.oz (nbe Systane Original) 99929 (prop Gly)
SPL v3
SPL
SPL Set ID 24c451c0-4cf9-37f3-e063-6394a90a895e
Route
OPHTHALMIC
Published
Effective Date 2025-03-27
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
Sodium Hydroxide Sodium Chloride Benzalkonium Chloride Hydrochloric Acid Potassium Chloride Boric Acid Hypromellose, Unspecified Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

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 dcotor
Dosage and Administration

Distributed by: CDMA, Inc.

Novi, MI 48375

Made in South Korea

Description

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

Section 44425-7

Other information

  • store at room temperature 15-25°C (59-77°F)
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 using
  • 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 in this product
Section 51727-6

Inactive ingredients

benzalkonium chloride, boric acid, hydrochloric acid, hypromellose, 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

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 dcotor
Dosage and Administration (34068-7)

Distributed by: CDMA, Inc.

Novi, MI 48375

Made in South Korea

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

  • store at room temperature 15-25°C (59-77°F)
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 using
  • 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 in this product
Section 51727-6 (51727-6)

Inactive ingredients

benzalkonium chloride, boric acid, hydrochloric acid, hypromellose, 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)

Active ingredients Purpose

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

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


Advanced Ingredient Data


Raw Label Data

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