Family Care Maximum Redness Relief Eye Drops 0.5oz 645, 2019 Dw

SPL v4

SPL

SPL Set ID 998bbfbc-f6d0-2a07-e053-2a95a90a30da

Route

OPHTHALMIC

Published

Effective Date 2019-12-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Naphazoline (0.3 mg) Glycerin (5 mg)

Inactive Ingredients

Boric Acid Edetic Acid Water Sodium Borate Benzalkonium Chloride

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-12-12

Description

Active ingredients Purposes Glycerin 0.5%........................................................................Eye lubricant Naphazoline HCl 0.03............................................................Eye redness reliever

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Directions

to open bottle, push cap down and twist counterclockwise
instill 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 44425-7

Other information

store at room temperature 15-25°F (59-77°F)

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

Section 50567-7

When using this product

do not touch tip of container to any surface to avoid contamination
replace cap after each use
pupils may become enlarged temporarily
overuse may cause more eye redness
remove contact lenses before using

Section 50569-3

Ask a doctor before use if you have narrow angle glaucoma.

Section 50570-1

Do not use if this solution changes color or becomes cloudy.

Section 51727-6

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, 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 eye due to minor eye irritations
for the temporary relief of burning and irritation due to dryness of the eye
for use as a protectant against further irritation or to relieve dryness of the eye

Section 55106-9

Active ingredients Purposes

Glycerin 0.5%........................................................................Eye lubricant

Naphazoline HCl 0.03............................................................Eye redness reliever

Structured Label Content

Indications and Usage (34067-9)

Directions

to open bottle, push cap down and twist counterclockwise
instill 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 44425-7 (44425-7)

Other information

store at room temperature 15-25°F (59-77°F)

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

Section 50567-7 (50567-7)

When using this product

do not touch tip of container to any surface to avoid contamination
replace cap after each use
pupils may become enlarged temporarily
overuse may cause more eye redness
remove contact lenses before using

Section 50569-3 (50569-3)

Ask a doctor before use if you have narrow angle glaucoma.

Section 50570-1 (50570-1)

Do not use if this solution changes color or becomes cloudy.

Section 51727-6 (51727-6)

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, 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 eye due to minor eye irritations
for the temporary relief of burning and irritation due to dryness of the eye
for use as a protectant against further irritation or to relieve dryness of the eye

Section 55106-9 (55106-9)

Active ingredients Purposes

Glycerin 0.5%........................................................................Eye lubricant

Naphazoline HCl 0.03............................................................Eye redness reliever

Advanced Ingredient Data

[{"name": "BORIC ACID", "unii": "R57ZHV85D4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NAPHAZOLINE", "unii": "H231GF11BV", "classCode": "ACTIB", "strengthNumerator": "0.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"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": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Directions to open bottle, push cap down and twist counterclockwise instill 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", "44425-7": "Other information store at room temperature 15-25°F (59-77°F)", "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 feel eye pain changes in vision occur redness or irritation of the eye lasts condition worsens or lasts more than 72 hours", "50567-7": "When using this product do not touch tip of container to any surface to avoid contamination replace cap after each use pupils may become enlarged temporarily overuse may cause more eye redness remove contact lenses before using", "50569-3": "Ask a doctor before use if you have narrow angle glaucoma.", "50570-1": "Do not use if this solution changes color or becomes cloudy.", "51727-6": "Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, 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 eye due to minor eye irritations for the temporary relief of burning and irritation due to dryness of the eye for use as a protectant against further irritation or to relieve dryness of the eye", "55106-9": "Active ingredients Purposes Glycerin 0.5%........................................................................Eye lubricant Naphazoline HCl 0.03............................................................Eye redness reliever"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:18.500692 · Updated: 2026-03-14T23:13:06.603726