drug facts

drug facts

SPL v5

SPL

SPL Set ID f9bdd126-d537-f8c7-e053-6394a90a5579

Route

ophthalmic

Published

Effective Date 2023-04-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

polyethylene glycol 400 (0.4 g) propylene glycol (0.3 g)

Inactive Ingredients

water

Identifiers & Packaging

Marketing Status

unapproved drug other active Since 2023-04-20

Description

Polyethylene Glycol 400, Propylene Glycol

Medication Information

Warnings and Precautions

For external use only

When using this product

■ do not touch tip of container to any surface to avoid contamination

■ replace cap after each use

■ avoid direct sunlight

Active Ingredient

Polyethylene Glycol 400, Propylene Glycol

Indications and Usage

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

Dosage and Administration

external use only

Description

Polyethylene Glycol 400, Propylene Glycol

Section 50565-1

keep out of reach of the children

Section 51727-6

boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sodium hyaluronate, sodium, hydroxide

Section 51945-4

Section 55105-1

for use as a protectant against further irritation or to relieve dryness of the eye

Structured Label Content

Warnings and Precautions (34071-1)

For external use only

When using this product

■ do not touch tip of container to any surface to avoid contamination

■ replace cap after each use

■ avoid direct sunlight

Active Ingredient (55106-9)

Polyethylene Glycol 400, Propylene Glycol

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

external use only

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sodium hyaluronate, sodium, hydroxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

for use as a protectant against further irritation or to relieve dryness of the eye

Advanced Ingredient Data

[{"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "ACTIB", "strengthNumerator": "0.4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "ACTIB", "strengthNumerator": "0.3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Instill 1 or 2 drops in the affectd eye(s) as needed", "34068-7": "external use only", "34071-1": "For external use only When using this product ■ do not touch tip of container to any surface to avoid contamination ■ replace cap after each use ■ avoid direct sunlight", "50565-1": "keep out of reach of the children", "51727-6": "boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sodium hyaluronate, sodium, hydroxide", "55105-1": "for use as a protectant against further irritation or to relieve dryness of the eye", "55106-9": "Polyethylene Glycol 400, Propylene Glycol"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:47.204072 · Updated: 2026-03-14T23:01:09.685872