Initial Drug Listing - Roycederm Stye Relief Eye Spray

Initial Drug Listing - Roycederm Stye Relief Eye Spray
SPL v1
SPL
SPL Set ID 3afa5e69-c285-fd73-e063-6294a90a93f9
Route
TOPICAL
Published
Effective Date 2025-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hypochlorous Acid (0.01 g)
Inactive Ingredients
Water Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-12
Description

Hypochlorous Acid 0.01%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • 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
Dosage and Administration

For cleansing of the eyelid and eyelash

area

Helps reduce bacteria that can cause skin

and eyelid irritation

Supports daily eyelid hygiene

Description

Hypochlorous Acid 0.01%

Section 50565-1

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

Section 50566-9
  • Redness, irritation,or discomfort persists or worsens
  • You experience allergic reaction or unexpected eye sensitivity
Section 50567-7
  • Do not touch tip of container to any surface
  • Avoid direct contact with the eyes
  • If contact with eyes occurs, rinse thoroughly with water
Section 50569-3
  • Redness, irritation, or discomfort persists or worsens
  • You experience allergic reaction or unexpected eye sensitivity
Section 50570-1

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

Section 51727-6

Electrolyzed water, Sodium chloride

Section 51945-4

Section 53413-1
Section 55105-1

Antiseptic / Eyelid Cleanser

Section 55106-9

Hypochlorous Acid 0.01%

Section 60561-8
  • Store at 15°-30°C(59°-86°F)
  • Do not freeze
  • Use within 90 days of opening
  • Forsingle-patient use only

Structured Label Content

Indications and Usage (34067-9)
  • 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
Dosage and Administration (34068-7)

For cleansing of the eyelid and eyelash

area

Helps reduce bacteria that can cause skin

and eyelid irritation

Supports daily eyelid hygiene

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)
  • Redness, irritation,or discomfort persists or worsens
  • You experience allergic reaction or unexpected eye sensitivity
Section 50567-7 (50567-7)
  • Do not touch tip of container to any surface
  • Avoid direct contact with the eyes
  • If contact with eyes occurs, rinse thoroughly with water
Section 50569-3 (50569-3)
  • Redness, irritation, or discomfort persists or worsens
  • You experience allergic reaction or unexpected eye sensitivity
Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Electrolyzed water, Sodium chloride

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)
Section 55105-1 (55105-1)

Antiseptic / Eyelid Cleanser

Section 55106-9 (55106-9)

Hypochlorous Acid 0.01%

Section 60561-8 (60561-8)
  • Store at 15°-30°C(59°-86°F)
  • Do not freeze
  • Use within 90 days of opening
  • Forsingle-patient use only

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:43.359971 · Updated: 2026-03-14T23:09:39.646164