FDA.reportPublic FDA data

Hi-Drops

Manufacturer
Tiki Talk LLC/Hi-Drops
Effective date
2021-01-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:36:53

Label at a glance#

ProductHi-Drops
Active ingredientNaphazoline Hydrochloride, Glycerin
Label structure10 sections

Indications and uses

relieves redness of the eye due to minor eye irritations temporary relief of burning and irritation due to dryness of the eyes protects against further irritation

Dosage and administration

instill 1 to 2 drops in the affected eye(s) up to four times daily.

Storage and handling

store at 15°-30° C (59°-86°F) keep tightly closed use before expiration date marked on the carton and bottle serious side effects associated with use of product may be reported to the phone number provided below

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - PURPOSE SECTION

Active IngredientsPurpose
Glycerin 0.25%Lubricant
Naphazoline HCL 0.012%Redness reliever

Uses

INDICATIONS & USAGE SECTION

  • relieves redness of the eye due to minor eye irritations
  • temporary relief of burning and irritation due to dryness of the eyes
  • protects against further irritation

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use if solution changes color or becomes cloudy.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • narrow angle glaucoma
  • high blood pressure
  • diabetes
  • any eye injuries or infection

When using this product

OTC - WHEN USING SECTION

  • do not touch tip container to any surface to avoid contamination
  • do not overuse as it may produce increased redness of the eye pupils may become enlarged temporarily
  • remove contact lenses before using
  • replace cap after use

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • instill 1 to 2 drops in the affected eye(s) up to four times daily.

Other information

STORAGE AND HANDLING SECTION

  • store at 15°-30° C (59°-86°F)
  • keep tightly closed
  • use before expiration date marked on the carton and bottle
  • serious side effects associated with use of product may be reported to the phone number provided below

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride, Boric Acid, Edetate Disodium, Purified Water, Sodium Borate.

Questions?

OTC - QUESTIONS SECTION

1-800-658-7271

SPL UNCLASSIFIED SECTION

Distributed by Tiki Talk LLC/Hi-Drops
848 N. Sunrise Blvd. Building B
Camano Island, WA 98282

PRINCIPAL DISPLAY PANEL - 7 mL Bottle Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

POCKET
SIZE

MAXIMUM
REDNESS RELIEF

HI–DROPS

✓RELIEVES ✓PROTECTS

✓SOOTHES ✓MOISTURIZES

Made in the U.S.A.

7 mL (0.24 fl oz)

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

STERILE EYE DROPS

Principal Display Panel - 7 mL Bottle Blister Pack
Principal Display Panel - 7 mL Bottle Blister Pack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046700glycerin 0.25 % / naphazoline HCl 0.012 % Ophthalmic SolutionPSN2
1046700glycerin 2.5 MG/ML / naphazoline hydrochloride 0.12 MG/ML Ophthalmic SolutionSCD2
1046700glycerin 0.25 % / naphazoline HCl 0.012 % Ophthalmic SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72254-123-012023-01-30C16284748780-1f386c64a-19a3-0266-e053-dadaa90a7c1aHi-Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72254-123-01Hi-Drops7 mL in 1 BOTTLESOLUTION/ DROPS72
72254-123-01Hi-Drops1 in 1 BLISTER PACKSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72254-123HI-DROPS (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [TIKI TALK LLC/HI-DROPS]2Legacy NDC, 2 package rows20210114_6005b280-9d6a-4da5-82a9-bffd4c8fb09c.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
72254-12372254-123-01

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
Naphazoline HydrochlorideMZ1131787DACTIB
GlycerinPDC6A3C0OXACTIB
Benzalkonium ChlorideF5UM2KM3W7IACT
Boric AcidR57ZHV85D4IACT
Edetate Disodium7FLD91C86KIACT
Water059QF0KO0RIACT
Sodium Borate91MBZ8H3QOIACT

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
d663c405-9c3b-43c8-917d-a6d4500f9d866005b280-9d6a-4da5-82a9-bffd4c8fb09c2021-01-12WarningsExact identifier
spl id: d663c405-9c3b-43c8-917d-a6d4500f9d86
spl set id: 6005b280-9d6a-4da5-82a9-bffd4c8fb09c

Reported adverse events (FAERS/openFDA)#

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