Proper labeling is essential to ensure the correct usage, dosage, and safety of ophthalmic preparations.
Labels must comply with regulatory standards and provide clear instructions.
Key elements include:
1) Product Name:
Clear identification of the product.
2) Dosage Form:
Specify whether it is a drop, ointment, or lotion.
3) Active Ingredient and Strength:
Name and concentration of the active ingredient.
4) Directions for Use:
“Shake well before use” for suspensions.
“Discard after X days of opening” for multi-dose containers.
5) Mandatory Statements:
“For ophthalmic use only.”
“Do not touch the dropper tip to any surface” to maintain sterility.
6) Storage Instructions:
E.g., “Store in a cool, dry place” or “Store at 2–8°C” if necessary.
Protect from light, if required.
7) Shelf-Life/Expiry Date:
Clearly state the expiry date.
Multi-dose solutions typically have a shorter in-use expiry (e.g., 4 weeks after opening).
8) Preservative-Free Warning:
For single-use units, indicate “Discard after use.”
Proper labeling ensures compliance with safety standards and clear communication to the user.