FDA.reportPublic FDA data

CIRCLE K sterile eye drops

Manufacturer
Lil' Drug Store Products, Inc. | KC Pharmaceuticals, Inc.
Effective date
2018-07-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:53:11

Label at a glance#

ProductCIRCLE K sterile eye drops
Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

relieves redness of the eye due to minor eye irritations

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tetrahydrozoline HCl 0.05%

Purpose

OTC - PURPOSE SECTION

Redness reliever

Uses

INDICATIONS & USAGE SECTION

  • relieves redness of the eye due to minor eye irritations

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

narrow angle glaucoma

When using this product

OTC - WHEN USING SECTION

  • 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

Stop use and ask a doctor if you experience

OTC - STOP USE SECTION

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

Store at 15 -30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free

1-877-507-6516

(M-F 8AM-4:30PM CST)

CIRCLE K sterile eye drops 15mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CIRCLE K sterile eye drops 15mLCIRCLE K sterile eye drops 15mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052943tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN1
1052943tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD1
1052943tetrahydrozoline hydrochloride 0.05 % Eye DropsSY1
1052943tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-8882-1CIRCLE K sterile eye drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS151
66715-8882-1CIRCLE K sterile eye drops1 in 1 BOXSOLUTION/ DROPS11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-8882CIRCLE K STERILE EYE DROPS (TETRAHYDROZOLINE HCL) SOLUTION/ DROPS [LIL' DRUG STORE PRODUCTS, INC.]1Current NDC, 2 package rows20250120_2c0e106c-16f6-ff4e-e063-6294a90a7dbb.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-888266715-8882-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB

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
CIRCLE K sterile eye dropsTETRAHYDROZOLINE HCLLil' Drug Store Products, Inc.2c0e106c-16f6-ff4e-e063-6294a90a7dbb2018-07-30WarningsExact identifier
ndc (package): 66715-8882-1
ndc (product): 66715-8882
ndc11 (package): 66715888201
spl id: 2c0e106c-16f3-ff4e-e063-6294a90a7dbb
spl set id: 2c0e106c-16f6-ff4e-e063-6294a90a7dbb

Reported adverse events (FAERS/openFDA)#

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