core values eye drops advanced relief (pld)

SPL v3

SPL

SPL Set ID f76dfeca-4e86-0b5d-e053-6294a90a29b9

Route

ophthalmic

Published

Effective Date 2023-03-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

dextran 70 (0.1 g) polyethylene glycol 400 (1 g) povidone (0.05 g) tetrahydrozoline

Inactive Ingredients

benzalkonium chloride boric acid edetate disodium water sodium borate sodium chloride

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2023-03-19

Purpose

Lubricant Lubricant Lubricant Redness reliever

Description

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

Medication Information

Warnings

For external use only

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

Purpose

Lubricant Lubricant Lubricant Redness reliever

Directions

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

Other Information

Store at 15 °-30°C (59°-86°F)

Inactive Ingredients

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

Description

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

Purposes

Lubricant

Redness reliever

Active Ingredients

Dextran 70 0.1%

Polyethylene glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.05%

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Us If You Have

narrow angle glaucoma

Core Values Eye Drops Advanced Relief

Stop Use and Ask A Doctor If You Experience

eye pain
changes in vision
continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

Structured Label Content

Warnings

For external use only

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

Directions

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

Other Information (Other information)

Store at 15 °-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

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

Purposes

Lubricant

Redness reliever

Active Ingredients

Dextran 70 0.1%

Polyethylene glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.05%

When Using This Product (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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Us If You Have (Ask a doctor before us if you have)

narrow angle glaucoma

Core Values Eye Drops Advanced Relief

Stop Use and Ask A Doctor If You Experience (Stop use and ask a doctor if you experience)

eye pain
changes in vision
continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

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": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TETRAHYDROZOLINE", "unii": "S9U025Y077", "classCode": "ACTIB", "strengthNumerator": "0.05", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"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", "Purposes": "Lubricant Lubricant Lubricant Redness reliever", "Warnings": "For external use only", "Directions": "Instill 1 or 2 drops in the affected eye(s) up to four times daily", "Other information": "Store at 15 °-30°C (59°-86°F)", "Active Ingredients": "Dextran 70 0.1% Polyethylene glycol 400 1% Povidone 1% Tetrahydrozoline HCl 0.05%", "Inactive ingredients": "benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride", "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", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Ask a doctor before us if you have": "narrow angle glaucoma", "Stop use and ask a doctor if you experience": "eye pain changes in vision continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:03.597705 · Updated: 2026-03-14T23:12:11.217358