Pure Eyes

Manufacturer
SAMSON PHARMACEUTICAL
Effective date
2026-04-21
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:54:45

Label at a glance#

ProductPure Eyes Sterile Eyes
Active ingredientNaphazoline Hydrochloride, Glycerin
Label structure10 sections

Indications and uses

♦ Relieve redness of the eye due to minor irritation ♦ Temporary relief of burning and irritation due to dryness of the eye ♦ Protects against further irritation

Dosage and administration

♦ Instill 1 to 2 drops in the affected eye(s) up to 4 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 effect associated with use of the product may be reported to the phone number provided below

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACT

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

ACTIVE INGREDIENTSPURPOSE
Naphazoline HCL 0.01%Redness reliever
Glycerin 0.25%Lubricant

Uses

INDICATIONS & USAGE SECTION

  • Relieve redness of the eye due to minor irritation
  • Temporary relief of burning and irritation due to dryness of the eye
  • 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

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
  • Do not overuse as it may products increased redness of the eye
  • Pupils may be come enlarged temporarily
  • Remove contact lenses before using
  • Replace cap after use

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep put of reach of children. Id 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 4 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 effect associated with use of the 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.

Question?

OTC - QUESTIONS SECTION

1-888-995-9935

SPL UNCLASSIFIED SECTION

Manufactured by:
Samson Pharmaceutical
Commerce, CA 90040
Made in USA

PRINCIPAL DISPLAY PANEL - 7 mL Bottle Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

POCKET SIZE

MAXIMUM
REDNESS RELIEF

Pure
Eyes®

STERILE
EYE DROPS

  • Relieves
  • Protects
  • Soothes
  • Moisturizes

Made in the U.S.A.

0.24 FL OZ (7ML)

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 SolutionPSN5
1046700glycerin 2.5 MG/ML / naphazoline hydrochloride 0.12 MG/ML Ophthalmic SolutionSCD5
1046700glycerin 0.25 % / naphazoline HCl 0.012 % Ophthalmic SolutionSY5

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130610466049750GTIN-13: 0610466049750
EAN-13: 0610466049750
GTIN-12: 610466049750
UPC-A: 610466049750
GTIN storage (14 digits): 00610466049750
pure-eyes-01.jpg

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
20146-7000-1Pure Eyes Sterile Eyes7 mL in 1 BOTTLESOLUTION/ DROPS75
20146-7000-1Pure Eyes Sterile Eyes1 in 1 BLISTER PACKSOLUTION/ DROPS15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GlycerinACTIVE INGREDIENTPDC6A3C0OX1
Naphazoline HydrochlorideACTIVE INGREDIENTMZ1131787D1
GlycerinACTIVE MOIETYPDC6A3C0OX1
NaphazolineACTIVE MOIETYH231GF11BV1
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W71
boric acidINACTIVE INGREDIENTR57ZHV85D41
edetate disodiumINACTIVE INGREDIENT7FLD91C86K1
sodium borateINACTIVE INGREDIENT91MBZ8H3QO1
waterINACTIVE INGREDIENT059QF0KO0R1

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
20146-700020146-7000-1

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
sodium borateSODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
boric acidBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sodium borateSODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
boric acidBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Pure Eyes Sterile EyesNAPHAZOLINE HYDROCHLORIDE AND GLYCERINSAMSON PHARMACEUTICALc0234e82-211f-4731-ac48-12db13b16e8a2026-04-21WarningsExact identifier
ndc (package): 20146-7000-1
ndc (product): 20146-7000
ndc11 (package): 20146700001
spl id: 103fe3bc-124a-4ce6-a1b1-fa96935d0fd9
spl set id: c0234e82-211f-4731-ac48-12db13b16e8a

Reported adverse events (FAERS/openFDA)#

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