Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID dcec9de2-d680-4829-9557-7ace9f506a3b
Route
OPHTHALMIC
Published
Effective Date 2010-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol (0.4 mL) Propylene Glycol (0.3 mL)
Inactive Ingredients
Boric Acid Calcium Chloride Chlorhexidine Gluconate Hydrochloric Acid Magnesium Chloride Potassium Chloride Water Sodium Chloride Zinc Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-04-28

Description

Active ingredients-------------------------------------------------Purpose Polyethylene Glycol 400 (0.4%)-----------------------------Lubricant Propylene Glycol (0.3%)---------------------------------------Lubricant


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Directions

  • Put 1 or 2 drops in the affected eye/s as needed.

Description

Active ingredients-------------------------------------------------Purpose Polyethylene Glycol 400 (0.4%)-----------------------------Lubricant Propylene Glycol (0.3%)---------------------------------------Lubricant

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if

  • you experience eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse or lasts more than 72 hours

Section 50567-7

When using this product

  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after each use

Section 50570-1

Do not use

  • if solution changes color or becomes cloudy
  • if you are sensitive or allergic to any ingredient in this product

Section 51727-6

Inactive ingredients: Boric Acid, Calcium Chloride, Chlorhexidine Gluconate, Hydrochloric Acid, Hydroxypropyl Guar,

Magnesium Chloride, Potassium Chloride, Purified Water, Sodium Chloride, Zinc Chloride

Section 51945-4

Enter section text here

Section 55105-1

Uses

For the temporary relief of burning and irritation due to eye dryness.

Section 55106-9

Active ingredients-------------------------------------------------Purpose

Polyethylene Glycol 400 (0.4%)-----------------------------Lubricant

Propylene Glycol (0.3%)---------------------------------------Lubricant


Structured Label Content

Indications and Usage (34067-9)

Directions

  • Put 1 or 2 drops in the affected eye/s as needed.

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 immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • you experience eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse or lasts more than 72 hours

Section 50567-7 (50567-7)

When using this product

  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after each use

Section 50570-1 (50570-1)

Do not use

  • if solution changes color or becomes cloudy
  • if you are sensitive or allergic to any ingredient in this product

Section 51727-6 (51727-6)

Inactive ingredients: Boric Acid, Calcium Chloride, Chlorhexidine Gluconate, Hydrochloric Acid, Hydroxypropyl Guar,

Magnesium Chloride, Potassium Chloride, Purified Water, Sodium Chloride, Zinc Chloride

Section 51945-4 (51945-4)

Enter section text here

Section 55105-1 (55105-1)

Uses

For the temporary relief of burning and irritation due to eye dryness.

Section 55106-9 (55106-9)

Active ingredients-------------------------------------------------Purpose

Polyethylene Glycol 400 (0.4%)-----------------------------Lubricant

Propylene Glycol (0.3%)---------------------------------------Lubricant


Advanced Ingredient Data


Raw Label Data

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