Signature Select High Performance Lubricant Eye Drops 15ml (pld)

Signature Select High Performance Lubricant Eye Drops 15ml (pld)
SPL v5
SPL
SPL Set ID 6f1f4f58-3208-4b06-9afb-c4beeed09314
Route
OPHTHALMIC
Published
Effective Date 2025-12-30
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
Aminomethylpropanol Benzalkonium Chloride Boric Acid Hypromelloses Potassium Chloride Water Sodium Chloride Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-05

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 (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 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

aminomethylpropanol, benzalkonium chloride as preservative, boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sorbitol

Section 53414-9

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

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°-30°C (59º-86ºF)

Questions Or Comments?

1-888-527-4276

Signature Select High Performance Lubricant Eye Drops 15ml


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 (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 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)

aminomethylpropanol, benzalkonium chloride as preservative, boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sorbitol

Section 53414-9 (53414-9)

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

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°-30°C (59º-86ºF)

Questions Or Comments? (Questions or Comments?)

1-888-527-4276

Signature Select High Performance Lubricant Eye Drops 15ml (Signature Select High Performance Lubricant Eye Drops 15mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)