Labeling of ophthalmic preparations MCQs With Answer

Proper labeling of ophthalmic preparations is essential for patient safety, sterility assurance, and regulatory compliance. This topic covers label elements such as product name, strength, concentration, preservative information, excipients, batch number, manufacturing and expiry dates, storage conditions, directions for use, warnings like “For ocular use only” and single‑use versus multi‑dose indications. B. Pharm students must understand regulatory requirements, beyond‑use dating, container‑closure system labeling, and instructions for suspension/ointment formulations. Emphasis on sterility, preservative compatibility (e.g., benzalkonium chloride), and patient counselling points is vital for correct dispensing and minimizing adverse ocular events. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which of the following is an essential item that must appear on the label of an ophthalmic solution?

• Batch number and manufacturing date
• Patient’s diagnosis
• Prescriber’s personal notes
• In-house lab test results

Correct Answer: Batch number and manufacturing date

Q2. The warning phrase that should be printed on ophthalmic products to prevent misuse is:

• For oral use only
• For external use only
• For ocular use only
• For topical use on skin only

Correct Answer: For ocular use only

Q3. Which information indicates whether an ophthalmic product is preservative‑containing or preservative‑free?

• Storage temperature
• Preservative name or “preservative‑free” statement
• Manufacturer’s logo
• Dosage schedule

Correct Answer: Preservative name or “preservative‑free” statement

Q4. What label instruction is most appropriate for an ophthalmic suspension?

• Shake well before use
• Keep refrigerated and do not shake
• Take after meals
• Apply as a patch

Correct Answer: Shake well before use

Q5. Which parameter on an ophthalmic label directly relates to sterility assurance after opening?

• Lot number
• Beyond‑use date or “discard after opening” period
• Manufacturer address
• Therapeutic indications

Correct Answer: Beyond‑use date or “discard after opening” period

Q6. For multi‑dose ophthalmic containers, which detail is crucial to minimize contamination risk?

• Color of the cap
• Presence of tamper‑evident seal and preservative information
• Price per milliliter
• Marketing slogan

Correct Answer: Presence of tamper‑evident seal and preservative information

Q7. Which preservative is commonly declared on labels of ophthalmic solutions?

• Paraben‑free label only
• Benzalkonium chloride (BAK)
• Sodium chloride
• Silicone oil

Correct Answer: Benzalkonium chloride (BAK)

Q8. The concentration expression appropriate for ophthalmic solutions on a label is:

• Percent w/v or mg/mL
• Grams per tablet
• Calories per dose
• International Units without amount

Correct Answer: Percent w/v or mg/mL

Q9. Which label statement is important for single‑use ophthalmic vials?

• Discard unused portion after first use
• Use within 30 days of opening
• Store at room temperature after opening
• Shake well before use

Correct Answer: Discard unused portion after first use

Q10. The label requirement that helps in tracing quality problems back to production is:

• Therapeutic class
• Batch or lot number
• Recommended retail price
• Physician’s name

Correct Answer: Batch or lot number

Q11. Which storage instruction is most commonly found on labels of heat‑sensitive ophthalmic products?

• Store below 8°C (refrigerate)
• Keep under direct sunlight
• Store in a freezer at −20°C
• Keep in a humid environment

Correct Answer: Store below 8°C (refrigerate)

Q12. A critical labeling phrase to warn patients about accidental ingestion is:

• May cause dryness
• Not for ingestion
• Take with food
• Apply twice daily

Correct Answer: Not for ingestion

Q13. Which legal/regulatory detail is generally required on labels in many countries?

• Manufacturer’s license number or marketing authorization number
• Doctor’s comments
• Complete manufacturing process
• Internal QC passing rates

Correct Answer: Manufacturer’s license number or marketing authorization number

Q14. For an ophthalmic ointment label, what additional instruction is commonly required?

• Apply with a cotton swab deep into the canal
• Apply a thin ribbon along the lower conjunctival sac
• Inject into subconjunctival space
• Heat before application

Correct Answer: Apply a thin ribbon along the lower conjunctival sac

Q15. Which label entry helps patients avoid overdosage with eyedrops?

• Number of drops per dose and frequency
• List of colorants used
• Manufacturing cost
• Company’s mission statement

Correct Answer: Number of drops per dose and frequency

Q16. The phrase “Use sterile solution only” on a label primarily indicates concern for:

• Osmolarity control
• Microbial contamination and ocular safety
• Flavor enhancement
• Packaging aesthetics

Correct Answer: Microbial contamination and ocular safety

Q17. Which label detail informs the user about osmotic balance suitable for the eye?

• Tonicity or isotonicity statement (e.g., isotonic with tears)
• Name of the packaging supplier
• Manufacturer’s profit margin
• Route of elimination

Correct Answer: Tonicity or isotonicity statement (e.g., isotonic with tears)

Q18. When an ophthalmic product contains a steroid, the label should include which warning?

• May increase intraocular pressure with prolonged use
• Will cure infections instantly
• Safe for all age groups without restriction
• No need for ocular follow‑up

Correct Answer: May increase intraocular pressure with prolonged use

Q19. Which label element is important for patients using multiple ophthalmic products to avoid interaction?

• Storage shelf life only
• Instructions on timing between different eye drops
• Company contact details only
• Packaging color code

Correct Answer: Instructions on timing between different eye drops

Q20. For pediatric ophthalmic labeling, which additional information is often necessary?

• Pediatric dosing instructions and concentration
• Adult clinical trial data
• Manufacturer’s marketing plan
• Discount coupons

Correct Answer: Pediatric dosing instructions and concentration

Q21. Which of the following is an acceptable way to express net contents on an ophthalmic label?

• Net volume: 5 mL
• One bottle only
• Will last for months
• Approximately some volume

Correct Answer: Net volume: 5 mL

Q22. The labeling term “sterile” on an ophthalmic product must be supported by:

• Appropriate sterility test data and sterile manufacturing claims
• Only visual inspection
• Marketing approval without tests
• Color matching certificate

Correct Answer: Appropriate sterility test data and sterile manufacturing claims

Q23. Which instruction is specifically useful on labels for ophthalmic antibiotics?

• Complete full course even if symptoms improve
• Use only when symptoms are severe
• Stop immediately when feeling better
• Mix with oral antibiotics

Correct Answer: Complete full course even if symptoms improve

Q24. What label precaution is important when an ophthalmic product contains a dye or colorant?

• May temporarily stain eyelids or contact lenses
• Increase systemic absorption
• Make the solution sterile
• Improve therapeutic index

Correct Answer: May temporarily stain eyelids or contact lenses

Q25. Which labeling instruction is recommended when dispensing ophthalmic products to contact lens wearers?

• Remove contact lenses before application if product may be absorbed by lenses
• Always keep lenses on during dosing
• Store lenses in the eye after instillation
• Clean lenses with the ophthalmic product

Correct Answer: Remove contact lenses before application if product may be absorbed by lenses

Q26. Which of the following must be included on the label to indicate potency of an ophthalmic steroid eye drop?

• Strength in mg/mL or percent
• Exact pH only
• Color of the bottle
• Batch printing date only

Correct Answer: Strength in mg/mL or percent

Q27. Which label statement helps ensure correct administration technique for eye ointments?

• Apply at bedtime unless directed otherwise
• Rinse mouth after application
• Do not refrigerate ointment
• Use as a nasal ointment

Correct Answer: Apply at bedtime unless directed otherwise

Q28. Under regulatory labeling, the expiry date on an ophthalmic product refers to:

• The date until which the product retains its labeled potency and sterility when unopened
• The date of patent filing
• The preferred selling date
• The date manufacturing began

Correct Answer: The date until which the product retains its labeled potency and sterility when unopened

Q29. What label advice reduces the risk of contamination during patient use?

• Do not touch dropper tip to any surface including the eye
• Always touch the tip to place it precisely
• Leave cap off between doses
• Share the bottle with family members

Correct Answer: Do not touch dropper tip to any surface including the eye

Q30. Which label element communicates the therapeutic purpose of the ophthalmic preparation to the dispenser?

• Indications or intended use (e.g., anti‑infective, anti‑inflammatory)
• Barcode number only
• Marketing tagline
• Packaging color

Correct Answer: Indications or intended use (e.g., anti‑infective, anti‑inflammatory)

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