Topcare Health Original Eye Drops (pld)

SPL v3

SPL

SPL Set ID 9c61a56a-c1a9-2846-e053-2995a90a755b

Route

OPHTHALMIC

Published

Effective Date 2020-02-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Tetrahydrozoline (0.05 g)

Inactive Ingredients

Benzalkonium Chloride Boric Acid Edetic Acid Water Sodium Borate Sodium Chloride

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-02-06

Description

Acive ingredient Tetrahydrozoline HCl.....0.05%

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Use

relieves redness of the eye due to minor eye irritations

Dosage and Administration

Directions

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

Description

Acive ingredient 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 50566-9

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

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 have narrow angle glaucoma

Section 51727-6

Inactive ingredients

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

Section 51945-4

Section 53414-9

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

Section 55105-1

Purpose

Tetrahydrozoline HCl........Redness reliever

Section 55106-9

Acive ingredient

Tetrahydrozoline HCl.....0.05%

Section 60561-8

Other information

store at 15º-30ºC (59º-86ºF)

Structured Label Content

Indications and Usage (34067-9)

Use

relieves redness of the eye due to minor eye irritations

Dosage and Administration (34068-7)

Directions

Instill 1 to 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 50566-9 (50566-9)

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

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 have narrow angle glaucoma

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Tetrahydrozoline HCl........Redness reliever

Section 55106-9 (55106-9)

Acive ingredient

Tetrahydrozoline HCl.....0.05%

Section 60561-8 (60561-8)

Other information

store at 15º-30ºC (59º-86ºF)

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": "EDETIC ACID", "unii": "9G34HU7RV0", "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": "TETRAHYDROZOLINE", "unii": "S9U025Y077", "classCode": "ACTIB", "strengthNumerator": "0.05", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use relieves redness of the eye due to minor eye irritations", "34068-7": "Directions Instill 1 to 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.", "50566-9": "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", "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, sodium chloride", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Tetrahydrozoline HCl........Redness reliever", "55106-9": "Acive ingredient Tetrahydrozoline HCl.....0.05%", "60561-8": "Other information store at 15º-30ºC (59º-86ºF)"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:33.512846 · Updated: 2026-03-14T23:02:10.811423