FDA.reportPublic FDA data

Initial Drug Listing - RoyceDerm Stye Relief Eye Spray

Manufacturer
RoyceDerm LLC
Effective date
2025-07-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:09:54

Label at a glance#

ProductRoyceDerm Stye Relief Eye Spray.
Active ingredientHYPOCHLOROUS ACID
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Hypochlorous Acid 0.01%

OTC - PURPOSE SECTION

Antiseptic / Eyelid Cleanser

DOSAGE & ADMINISTRATION SECTION

For cleansing of the eyelid and eyelash
area

Helps reduce bacteria that can cause skin
and eyelid irritation

Supports daily eyelid hygiene

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

In the eyes · If the solution changes color or becomes cloudy

OTC - ASK DOCTOR SECTION

  • Redness, irritation, or discomfort persists or worsens
  • You experience allergic reaction or unexpected eye sensitivity

OTC - WHEN USING SECTION

  • Do not touch tip of container to any surface
  • Avoid direct contact with the eyes
  • If contact with eyes occurs, rinse thoroughly with water

OTC - STOP USE SECTION

  • Redness, irritation,or discomfort persists or worsens
  • You experience allergic reaction or unexpected eye sensitivity

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

  • Spray directly onto closed eyelids or applyusing a sterile cotton pad
  • Gently wipe acrossthe eyelid and lash line
  • Use 1-2 times daily oras recommended by your eye care professional
  • If you wear contact lenses, please removethem before use
  • For external eyelid use only

OTHER SAFETY INFORMATION

  • Store at 15°-30°C(59°-86°F)
  • Do not freeze
  • Use within 90 days of opening
  • Forsingle-patient use only

INACTIVE INGREDIENT SECTION

Electrolyzed water, Sodium chloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

stye spraystye spray

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2721462hypochlorous acid 0.01 % Topical SprayPSN1
2721462hypochlorous acid 0.1 MG/ML Topical SpraySCD1
2721462hypochlorous acid 0.01 % Topical SpraySY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-006-01RoyceDerm Stye Relief Eye Spray.100 g in 1 BOTTLE, SPRAYSPRAY1001

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85424-00685424-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
HYPOCHLOROUS ACID712K4CDC10ACTIB

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
RoyceDerm Stye Relief Eye Spray.HYPOCHLOROUS ACIDRoyceDerm LLC3afa5e69-c285-fd73-e063-6294a90a93f92025-07-28WarningsExact identifier
ndc (package): 85424-006-01
ndc (product): 85424-006
ndc11 (package): 85424000601
spl id: 3afa5e69-c286-fd73-e063-6294a90a93f9
spl set id: 3afa5e69-c285-fd73-e063-6294a90a93f9

Reported adverse events (FAERS/openFDA)#

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