Topcare Health Lubricant Eye Drops (pld)

Topcare Health Lubricant Eye Drops (pld)
SPL v3
SPL
SPL Set ID 9c6284f9-00bb-37b5-e053-2a95a90ae2ee
Route
OPHTHALMIC
Published
Effective Date 2020-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Propylene Glycol (0.3 g) Polyethylene Glycol 400 (0.4 g)
Inactive Ingredients
Sodium Chloride Zinc Chloride Calcium Chloride Hypromellose, Unspecified Magnesium Chloride Potassium Chloride Water Sodium Borate Benzalkonium Chloride Boric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-07

Description

Active ingredients Polyethylene glycol 400 0.4% Propylene glycol 0.3%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

for the temporary relief of burning and irritation due to dryness of the eye

Dosage and Administration

Directions

  • Instill 1 or 2 drops in the affected eye(s) as needed
  • Children under 6 years of age: ask a doctor
Description

Active ingredients Polyethylene glycol 400 0.4% Propylene glycol 0.3%

Section 50565-1

Keep out of 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(s) gets worse or lasts more than 72 hours
Section 50567-7

When using this product

  • do not touch the tip of container to any surface to avoid contamination
  • replace cap after each use
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 as preservative, boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, zinc chloride

Section 51945-4

Section 55105-1

Purpose

Polyethylene glycol 400.....Lubricant

Propylene glycol........Lubricant

Section 55106-9

Active ingredients

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

Section 60561-8

Other information

  • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • Store at room temperature

Structured Label Content

Indications and Usage (34067-9)

Uses

for the temporary relief of burning and irritation due to dryness of the eye

Dosage and Administration (34068-7)

Directions

  • Instill 1 or 2 drops in the affected eye(s) as needed
  • Children under 6 years of age: ask a doctor
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 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(s) gets worse or lasts more than 72 hours
Section 50567-7 (50567-7)

When using this product

  • do not touch the tip of container to any surface to avoid contamination
  • replace cap after each use
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 as preservative, boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, zinc chloride

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Polyethylene glycol 400.....Lubricant

Propylene glycol........Lubricant

Section 55106-9 (55106-9)

Active ingredients

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

Section 60561-8 (60561-8)

Other information

  • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • Store at room temperature

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)