Exchange Select Artificial Tears (pld)

Exchange Select Artificial Tears (pld)
SPL v4
SPL
SPL Set ID 9e478343-8ae7-823e-e053-2995a90a84ed
Route
OPHTHALMIC
Published
Effective Date 2020-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 400 (1 g) Hypromellose, Unspecified (0.2 g) Glycerin
Inactive Ingredients
Dextrose Sodium Chloride Sodium Phosphate, Monobasic Sodium Phosphate, Dibasic Sodium Citrate Benzalkonium Chloride Water Potassium Chloride Sodium Bicarbonate Edetic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-12

Description

Active ingredients Glycerin 0.2% Hypromellose 0.2% Polyethylene glycol 400 1%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

  • For temporary relief of burning and irritation due to dryness of the eye
  • for protection against further irritation
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 Glycerin 0.2% Hypromellose 0.2% Polyethylene glycol 400 1%

Section 50565-1

Keep out of reach of children. If accidentally 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
  • continued redness or irritation of the eye or if the condition worsens or persists for 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 using. Keep container tightly closed.
  • remove contact lens bvefore using
Section 50570-1

Do not use this product if solution changes color or becomes cloudy

Section 51727-6

Inactive ingredients

dextrose, sodium chloride, potassium chloride, sodium phosphate monobasic, sodium phosphate dibasic, sodium bicarbonate, sodium citrate, edetate disodium, benzalkonium chloride, purified water.

Section 51945-4

Section 53414-9

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

Section 55105-1

Purpose

Glycerin....Lubricant

Hypromellose....Lubricant

Polyethylene glycol 400....Lubricant

Section 55106-9

Active ingredients

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 400 1%

Section 60561-8

Other information

  • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • Store at 15º-30ºC (59º-86ºF)

Structured Label Content

Indications and Usage (34067-9)

Uses

  • For temporary relief of burning and irritation due to dryness of the eye
  • for protection against further irritation
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 accidentally 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
  • continued redness or irritation of the eye or if the condition worsens or persists for 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 using. Keep container tightly closed.
  • remove contact lens bvefore using
Section 50570-1 (50570-1)

Do not use this product if solution changes color or becomes cloudy

Section 51727-6 (51727-6)

Inactive ingredients

dextrose, sodium chloride, potassium chloride, sodium phosphate monobasic, sodium phosphate dibasic, sodium bicarbonate, sodium citrate, edetate disodium, benzalkonium chloride, purified water.

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)

Purpose

Glycerin....Lubricant

Hypromellose....Lubricant

Polyethylene glycol 400....Lubricant

Section 55106-9 (55106-9)

Active ingredients

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 400 1%

Section 60561-8 (60561-8)

Other information

  • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • Store at 15º-30ºC (59º-86ºF)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)