3866e2c1-051b-0b01-e063-6394a90af5cf

SPL v4

SPL

SPL Set ID 3866e2c1-051b-0b01-e063-6394a90af5cf

Route

ophthalmic

Published

Effective Date 2025-06-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

glycerin (2 mg)

Inactive Ingredients

dextrose magnesium chloride amlisimod sodium acetate water hydrochloric acid sodium hydroxide

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2025-06-25

Dosage and Administration

Instill 1 to 2 drops in the affected eye(s) as needed.

Purpose

Lubricant

Description

Lubricant

Medication Information

Warnings and Precautions

For external use only.

Do not use if solution changes color or becomes cloudy.

When using this product:

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

- do not reuse

- once opened, discard

Stop use and ask a doctor if you experience:

- eye pain

- changes in vision

- continued redness or irritation

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

Glycerin 0.2% – Lubricant

Indications and Usage

For the temporary relief of burning and irritation due to dryness of the eye.

Purpose

Lubricant

Dosage and Administration

Instill 1 to 2 drops in the affected eye(s) as needed.

Description

Lubricant

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients: dextrose, magnesium chloride, purified water, Silk-Derived Protein-4 (SDP-4), sodium acetate. May also contain hydrochloric acid and/or sodium hydroxide to adjust PH

Section 51945-4

30 vials of 6 pouches each containing 5 sterile dispensers 0.01 FL OZ (0.35 mL EA)

Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Do not use if solution changes color or becomes cloudy.

When using this product:

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

- do not reuse

- once opened, discard

Stop use and ask a doctor if you experience:

- eye pain

- changes in vision

- continued redness or irritation

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient (55106-9)

Glycerin 0.2% – Lubricant

Indications and Usage (34067-9)

For the temporary relief of burning and irritation due to dryness of the eye.

Purpose

Lubricant

Dosage and Administration

Instill 1 to 2 drops in the affected eye(s) as needed.

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 51727-6 (51727-6)

Inactive ingredients: dextrose, magnesium chloride, purified water, Silk-Derived Protein-4 (SDP-4), sodium acetate. May also contain hydrochloric acid and/or sodium hydroxide to adjust PH

Section 51945-4 (51945-4)

30 vials of 6 pouches each containing 5 sterile dispensers 0.01 FL OZ (0.35 mL EA)

Advanced Ingredient Data

[{"name": "DEXTROSE", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "MAGNESIUM CHLORIDE", "unii": "02F3473H9O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMLISIMOD", "unii": "K80BPM67OF", "classCode": "IACT", "strengthNumerator": "10", "strengthDenominator": "1000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM ACETATE", "unii": "4550K0SC9B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "For the temporary relief of burning and irritation due to dryness of the eye.", "34071-1": "For external use only. Do not use if solution changes color or becomes cloudy. When using this product: - do not touch tip of container to any surface to avoid contamination - do not reuse - once opened, discard Stop use and ask a doctor if you experience: - eye pain - changes in vision - continued redness or irritation Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Inactive ingredients: dextrose, magnesium chloride, purified water, Silk-Derived Protein-4 (SDP-4), sodium acetate. May also contain hydrochloric acid and/or sodium hydroxide to adjust PH", "51945-4": "30 vials of 6 pouches each containing 5 sterile dispensers 0.01 FL OZ (0.35 mL EA)", "55106-9": "Glycerin 0.2% – Lubricant", "Purpose": "Lubricant", "Dosage and Administration": "Instill 1 to 2 drops in the affected eye(s) as needed."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:32.500143 · Updated: 2026-03-14T23:09:21.323328