Family Care Eye Drops Advanced Formula 0.5oz 511a (2020)

SPL v8

SPL

SPL Set ID 716d2f37-ae19-42b1-9d85-d07777dedaed

Route

OPHTHALMIC

Published

Effective Date 2017-07-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Tetrahydrozoline (0.5 mg) Dextran 70 (1 mg) Polyethylene Glycol 400 (10 mg) Povidone

Inactive Ingredients

Benzalkonium Chloride Boric Acid Edetate Disodium Water Sodium Chloride Sodium Borate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-11-25

Description

Active ingredients Purpose Tetrahydrozoline HCl 0.05%.............................................................Redness reliever Dextran 70 0.1%............................................................................Lubricant Polyethylene glycol 400 1%.............................................................Lubricant Povidone 1%.................................................................................Lubricant

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Directions

to open bottle, push cap down and twist counter-clockwise
put 1 to 2 drops in the affected eye(s) up to 4 times daily
children under 6 years of age: ask a doctor

Dosage and Administration

Distributed by:

United Exchange Corp.

Cypress, CA 90630 USA

Made in South Korea

Description

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

you feel eye pain
changes in vision occur
redness or irritation of the eye persists
condition worsens or lasts more than 72 hours

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 chloride, and sodium borate

Section 51945-4

Section 53414-9

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

Section 55105-1

Uses

for the relief of redness of the eyes due to minor eye irritations
for use as a protectant against further irritation or to relieve dryness of the eye

Section 55106-9

Active ingredients Purpose

Tetrahydrozoline HCl 0.05%.............................................................Redness reliever

Dextran 70 0.1%............................................................................Lubricant

Polyethylene glycol 400 1%.............................................................Lubricant

Povidone 1%.................................................................................Lubricant

Section 60561-8

Other information

store at 15° to 25°C (59° to 77°F)

Structured Label Content

Indications and Usage (34067-9)

Directions

to open bottle, push cap down and twist counter-clockwise
put 1 to 2 drops in the affected eye(s) up to 4 times daily
children under 6 years of age: ask a doctor

Dosage and Administration (34068-7)

Distributed by:

United Exchange Corp.

Cypress, CA 90630 USA

Made in South Korea

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

you feel eye pain
changes in vision occur
redness or irritation of the eye persists
condition worsens or lasts more than 72 hours

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 chloride, and sodium borate

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)

Uses

for the relief of redness of the eyes due to minor eye irritations
for use as a protectant against further irritation or to relieve dryness of the eye

Section 55106-9 (55106-9)

Active ingredients Purpose

Tetrahydrozoline HCl 0.05%.............................................................Redness reliever

Dextran 70 0.1%............................................................................Lubricant

Polyethylene glycol 400 1%.............................................................Lubricant

Povidone 1%.................................................................................Lubricant

Section 60561-8 (60561-8)

Other information

store at 15° to 25°C (59° to 77°F)

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 CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BORATE", "unii": "91MBZ8H3QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TETRAHYDROZOLINE", "unii": "S9U025Y077", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DEXTRAN 70", "unii": "7SA290YK68", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Directions to open bottle, push cap down and twist counter-clockwise put 1 to 2 drops in the affected eye(s) up to 4 times daily children under 6 years of age: ask a doctor", "34068-7": "Distributed by: United Exchange Corp. Cypress, CA 90630 USA Made in South Korea", "34071-1": "Warnings For external use only", "50565-1": "Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if you feel eye pain changes in vision occur redness or irritation of the eye persists condition worsens or lasts more than 72 hours", "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 chloride, and sodium borate", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Uses for the relief of redness of the eyes due to minor eye irritations for use as a protectant against further irritation or to relieve dryness of the eye", "55106-9": "Active ingredients Purpose Tetrahydrozoline HCl 0.05%.............................................................Redness reliever Dextran 70 0.1%............................................................................Lubricant Polyethylene glycol 400 1%.............................................................Lubricant Povidone 1%.................................................................................Lubricant", "60561-8": "Other information store at 15° to 25°C (59° to 77°F)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:49.022592 · Updated: 2026-03-14T23:13:18.140905