SPL v8
SPL
SPL Set ID 2a2aa620-ca63-4698-88fd-fc263b8fa0d1
Route
OPHTHALMIC
Published
Effective Date 2019-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 400 (0.4 g) Propylene Glycol (0.3 g)
Inactive Ingredients
Boric Acid Hypromelloses Potassium Chloride Water Sodium Chloride Sodium Hydroxide Hydrochloric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-30

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 of the eye due to dryness of the eye

Dosage and Administration

Directions

• Instill 1 or 2 drops in the affected eye(s) as needed

Description

Active ingredients Polyethylene glycol 400  0.4% Propylene glycol   0.3%

Section 42228-7

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

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 feel eye pain

• changes in vision occur

• redness or irritation of the eye(s) gets worse, persists 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

• do not reuse

  • once opened, discard
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

boric acid, hypromellose, potassium chloride, purified water, sodium chloride.  May contain sodium hydroxide and/or hydrochloric acid to adjust pH.

Section 51945-4

Section 53413-1

Questions or comments?   Call 1-888-527-4276

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

  • store at 15°-25°C (59°-77°F)
  • use only if single-use container is intact
  • use before expiration date marked on container
  • RETAIN THIS CARTON FOR FUTURE REFERENCE

Structured Label Content

Indications and Usage (34067-9)

Uses

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

Dosage and Administration (34068-7)

Directions

• Instill 1 or 2 drops in the affected eye(s) as needed

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42228-7 (42228-7)

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

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 feel eye pain

• changes in vision occur

• redness or irritation of the eye(s) gets worse, persists 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

• do not reuse

  • once opened, discard
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

boric acid, hypromellose, potassium chloride, purified water, sodium chloride.  May contain sodium hydroxide and/or hydrochloric acid to adjust pH.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?   Call 1-888-527-4276

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

  • store at 15°-25°C (59°-77°F)
  • use only if single-use container is intact
  • use before expiration date marked on container
  • RETAIN THIS CARTON FOR FUTURE REFERENCE

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)