CareOne Maximum Strength Redness Relief

Manufacturer
FOODHOLD U.S.A., LLC
Effective date
2021-11-17
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:26:55

Label at a glance#

ProductCareOne Maximum Strength Redness Relief
Active ingredientGLYCERIN, NAPHAZOLINE HYDROCHLORIDE
Label structure14 sections

Storage and handling

Other information store at room temperature 20-25°C (68-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

Glycerin 0.5%................................... Eye Lubricant

Naphazoline HCl 0.03%....................Eye Redness reliever

OTC - PURPOSE SECTION

Uses

  • for the relief of redness of the eye due to minor eye irritations
  • for the temporary relief of burning and irritation due to the dryness of the eye
  • for use as a protectant against further irritation or dryness of the eye

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use if solution changes color or becomes cloudy.

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE SECTION

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

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

DOSAGE & ADMINISTRATION SECTION

Distributed by:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

Made in South Korea

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4152941529

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-79041520-790-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
427c17eb-ffa9-585b-e063-6394a90a92007cb26c4f-0707-4022-8528-30fdfffdb9e52025-10-31WarningsExact identifier
spl set id: 7cb26c4f-0707-4022-8528-30fdfffdb9e5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.