Otc - Active Ingredient
Hypochlorous Acid 0.01%
Roycederm Stye Relief Eye Spray. Spray
FDA Label NDC 85424-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Roycederm Llc for the product Roycederm Stye Relief Eye Spray. (NDC 85424-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, dosage & administration, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic / Eyelid Cleanser
Dosage & Administration
For cleansing of the eyelid and eyelash
area
Helps reduce bacteria that can cause skin
and eyelid irritation
Supports daily eyelid hygiene
Warnings
For external use only
Otc - Do Not Use
In the eyes · If the solution changes color or becomes cloudy
Otc - Ask Doctor
- Redness, irritation, or discomfort persists or worsens
- You experience allergic reaction or unexpected eye sensitivity
Otc - When Using
- 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
- Redness, irritation,or discomfort persists or worsens
- You experience allergic reaction or unexpected eye sensitivity
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Indications & 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
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
Electrolyzed water, Sodium chloride
Otc - Questions
- [email protected]
- www.roycederm.com
Package Label.Principal Display Panel
Stye Spray (Stye)
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