Careone Eye Drops Seasonal Relief

Manufacturer
FoodHold U.S.A LLC
Effective date
2019-05-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:59:23

Label at a glance#

ProductCareone Eye Drops Seasonal Relief
Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE
Label structure14 sections

Storage and handling

some users may exprience a brief tingling sensation store between 15-25ºC (59-77ºF)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purposes

Tetrahydrozoline HCl 0.05%.......Eye redness reliever

Zinc sulfate 0.25%......................Eye astringent

OTC - PURPOSE SECTION

Uses

  • for temporary relief of discomfort and redness of the eye due to minor eye irritations

WARNINGS SECTION

For external use only

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

When using this product

  • pupils may become enlarged temporarily
  • overuse may cause more eye redness
  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

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
  • put 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

  • some users may exprience a brief tingling sensation
  • store between 15-25ºC (59-77ºF)

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-877-846-9949

DOSAGE & ADMINISTRATION SECTION

Distributed by:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

86533.286533.2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSN2
1043249tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCD2
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSY2
1043249Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-653-152022-01-28C16284748780-1d6a99b39-ebd7-a426-e053-dadaa90af4c2Careone Eye Drops Seasonal Relief 0.5 oz (NBE Visine AC) 86533 2018

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-653-15Careone Eye Drops Seasonal Relief1 in 1 BOXSOLUTION/ DROPS12
41520-653-15Careone Eye Drops Seasonal Relief15 mL in 1 BOTTLESOLUTION/ DROPS152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-653CAREONE EYE DROPS SEASONAL RELIEF (TETRAHYDROZOLINE HCL AND ZINC SULFATE) SOLUTION/ DROPS [FOODHOLD U.S.A LLC]2Legacy NDC, 2 package rows20190502_76ca7211-8d4f-f0e1-e053-2991aa0aff8f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-65341520-653-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML · Source PDF

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
87dccaf8-1fe9-516f-e053-2a95a90abf5b76ca7211-8d4f-f0e1-e053-2991aa0aff8f2019-05-01WarningsExact identifier
spl id: 87dccaf8-1fe9-516f-e053-2a95a90abf5b
spl set id: 76ca7211-8d4f-f0e1-e053-2991aa0aff8f

Reported adverse events (FAERS/openFDA)#

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