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SPL v7

SPL

SPL Set ID 5c5d6c13-9b51-48f0-8627-b60b0f707fd3

Route

OPHTHALMIC

Published

Effective Date 2022-05-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dextran 70 (100 mg) Polyethylene Glycol 400 (1000 mg) Povidone (50 mg) Tetrahydrozoline

Inactive Ingredients

Benzalkonium Chloride Boric Acid Edetate Disodium Water Sodium Borate Sodium Chloride

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2019-02-19 Until 2027-01-31

Description

Active ingredients Dextran 70 0.1% Polyethylene glycol 400 1% Povidone 1% Tetrahydrozoline HCl 0.05%

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

relieves redness of the eye due to minor eye irritations
as a lubricant to prevent further irritation or to relieve dryness of the eye

Dosage and Administration

Directions

Instill 1 or 2 drops in the affected eye(s) up to 4 times daily.

Description

Active ingredients Dextran 70 0.1% Polyethylene glycol 400 1% Povidone 1% Tetrahydrozoline HCl 0.05%

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 50567-7

When using this product

pupils may become enlarged temporarily
to avoid contamination, do not touch tip of container to any surface. Replace cap after using
if solution changes color or becomes cloudy, do not use
overuse may produce increased redness of the eye
remove contact lens before using

Section 50569-3

Ask a doctor before use if you havenarrow angle glaucoma

Section 51727-6

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

Section 53414-9

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

Section 55105-1

Purposes

Dextran 70...Lubricant

Polyethylene glycol 400...Lubricant

Povidone...Lubricant

Tetrahydrozoline HCl...Redness reliever

Section 55106-9

Active ingredients

Dextran 70 0.1%

Polyethylene glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.05%

Section 60561-8

Other information

Store at 15°-30°C (59°-86°F)

Questions Or Comments?

1-888-527-4276

Leader Advanced Relief Eye Drops 15ml

Structured Label Content

Indications and Usage (34067-9)

Uses

relieves redness of the eye due to minor eye irritations
as a lubricant to prevent further irritation or to relieve dryness of the eye

Dosage and Administration (34068-7)

Directions

Instill 1 or 2 drops in the affected eye(s) up to 4 times daily.

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 50567-7 (50567-7)

When using this product

pupils may become enlarged temporarily
to avoid contamination, do not touch tip of container to any surface. Replace cap after using
if solution changes color or becomes cloudy, do not use
overuse may produce increased redness of the eye
remove contact lens before using

Section 50569-3 (50569-3)

Ask a doctor before use if you havenarrow angle glaucoma

Section 51727-6 (51727-6)

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Dextran 70...Lubricant

Polyethylene glycol 400...Lubricant

Povidone...Lubricant

Tetrahydrozoline HCl...Redness reliever

Section 55106-9 (55106-9)

Active ingredients

Dextran 70 0.1%

Polyethylene glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.05%

Section 60561-8 (60561-8)

Other information

Store at 15°-30°C (59°-86°F)

Questions Or Comments? (Questions or comments?)

1-888-527-4276

Leader Advanced Relief Eye Drops 15ml (Leader Advanced Relief Eye Drops 15mL)

Advanced Ingredient Data

[{"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BORIC ACID", "unii": "R57ZHV85D4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BORATE", "unii": "91MBZ8H3QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTRAN 70", "unii": "7SA290YK68", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "ACTIB", "strengthNumerator": "1000", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "ACTIB", "strengthNumerator": "1000", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "TETRAHYDROZOLINE", "unii": "S9U025Y077", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses relieves redness of the eye due to minor eye irritations as a lubricant to prevent further irritation or to relieve dryness of the eye", "34068-7": "Directions Instill 1 or 2 drops in the affected eye(s) up to 4 times daily.", "34071-1": "Warnings For external use only", "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.", "50567-7": "When using this product pupils may become enlarged temporarily to avoid contamination, do not touch tip of container to any surface. Replace cap after using if solution changes color or becomes cloudy, do not use overuse may produce increased redness of the eye remove contact lens before using", "50569-3": "Ask a doctor before use if you have narrow angle glaucoma", "51727-6": "Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "55105-1": "Purposes Dextran 70...Lubricant Polyethylene glycol 400...Lubricant Povidone...Lubricant Tetrahydrozoline HCl...Redness reliever", "55106-9": "Active ingredients Dextran 70 0.1% Polyethylene glycol 400 1% Povidone 1% Tetrahydrozoline HCl 0.05%", "60561-8": "Other information Store at 15°-30°C (59°-86°F)", "Questions or comments?": "1-888-527-4276"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:35.368226 · Updated: 2026-03-14T23:14:12.168159