Specimen labels for drugs and cosmetics MCQs With Answer

Accurate specimen labels for drugs and cosmetics are essential for safety, regulatory compliance, and quality control. This set of Specimen labels for drugs and cosmetics MCQs With Answer focuses on labeling regulations, mandatory label elements (brand and generic names, strength, batch number, manufacturing and expiry dates), storage and handling instructions, INCI ingredient declaration, allergen warnings, tamper-evident features, barcodes/serialization, and stability labeling for samples. Designed for B.Pharm students, the questions emphasize real-world applications, regulatory standards (CDSCO/FDA/USP), readability, and pharmacovigilance considerations. Use these MCQs to reinforce label design principles, inspection criteria, and documentation practices. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which of the following is considered a primary element that must appear on a drug product label?

• Manufacturer’s annual revenue
• Batch (lot) number
• Pharmacist signature
• Barcode color

Correct Answer: Batch (lot) number

Q2. What is the main purpose of including an expiry date on a drug label?

• To indicate when to reorder stock
• To show when the product was packaged
• To indicate the date after which the product should not be used for safety and potency reasons
• To satisfy marketing requirements

Correct Answer: To indicate the date after which the product should not be used for safety and potency reasons

Q3. For cosmetics, INCI names are required primarily to:

• Provide marketing benefits
• Uniformly list ingredients using standardized nomenclature
• Replace label claims
• Indicate batch number

Correct Answer: Uniformly list ingredients using standardized nomenclature

Q4. Which regulatory authority is responsible for approval and labeling regulation of drugs in India?

• EMA
• FDA (US)
• CDSCO
• WHO

Correct Answer: CDSCO

Q5. A stability sample label should always include which of the following elements?

• Prescriber’s handwriting
• Storage condition and sampling date
• Manufacturer’s profit margin
• Marketing slogan

Correct Answer: Storage condition and sampling date

Q6. Which symbol on a label indicates that the product should be kept between 2°C and 8°C?

• Open jar symbol
• Thermometer icon with 2–8°C or text ‘Refrigerate’
• Flame icon
• Do not reuse symbol

Correct Answer: Thermometer icon with 2–8°C or text ‘Refrigerate’

Q7. Tamper-evident features on packaging are primarily intended to:

• Improve product aesthetics
• Indicate if the product has been opened or altered
• Reduce manufacturing costs
• Provide ingredient lists

Correct Answer: Indicate if the product has been opened or altered

Q8. Which labeling element is particularly important for parenteral (injectable) products?

• Suggested retail price
• Route of administration and dilution instructions
• Promotional images
• Cosmetic claims

Correct Answer: Route of administration and dilution instructions

Q9. In cosmetics labeling, a “may contain” list is used to:

• Quantify each ingredient percentage
• List potential trace ingredients present from color additives
• Replace INCI names
• Provide storage instructions

Correct Answer: List potential trace ingredients present from color additives

Q10. Which of the following is a key reason for printing both generic and brand names on drug labels?

• To increase the label size
• To facilitate correct drug identification and reduce medication errors
• To comply with cosmetics law
• To show pricing differences

Correct Answer: To facilitate correct drug identification and reduce medication errors

Q11. For patient safety, minimum font size and legibility on drug labels are specified to ensure:

• That the label looks modern
• Readability of critical information such as dose, strength, and warnings
• Longer label content
• Lower printing costs

Correct Answer: Readability of critical information such as dose, strength, and warnings

Q12. Serialization and barcodes on pharmaceutical labels primarily help with:

• Reducing product weight
• Anti-counterfeiting, track-and-trace and inventory management
• Making labels more colorful
• Replacing ingredient lists

Correct Answer: Anti-counterfeiting, track-and-trace and inventory management

Q13. Which statement about “retest date” on labels is true?

• Retest date always equals expiry date
• Retest date indicates when the product should be re-evaluated for stability rather than discarded
• Retest dates are only used for cosmetics
• Retest date is the manufacturing date

Correct Answer: Retest date indicates when the product should be re-evaluated for stability rather than discarded

Q14. Labeling that warns “Keep out of reach of children” is required because:

• It is a marketing phrase
• It reduces legal liability only
• It provides a safety precaution to prevent accidental ingestion or misuse
• It increases sales to parents

Correct Answer: It provides a safety precaution to prevent accidental ingestion or misuse

Q15. Which labeling practice is important when repackaging bulk drug products into unit-dose containers?

• Omit expiry date to save space
• Ensure the unit-dose label includes drug name, strength, lot number, and expiry or beyond-use date
• Only include the brand logo
• Use handwritten vague instructions

Correct Answer: Ensure the unit-dose label includes drug name, strength, lot number, and expiry or beyond-use date

Q16. A cosmetic product label claiming “dermatologically tested” must be supported by:

• Consumer opinions only
• Appropriate evidence from tests or studies demonstrating the claim
• No evidence, it’s a voluntary claim
• Manufacturing plant photos

Correct Answer: Appropriate evidence from tests or studies demonstrating the claim

Q17. Which of the following must be declared on drug labels to aid pharmacovigilance?

• Marketing campaign dates
• Manufacturer name, batch number, and contact information for adverse event reporting
• Average customer rating
• Sales territory

Correct Answer: Manufacturer name, batch number, and contact information for adverse event reporting

Q18. For export of cosmetics, what labeling consideration is crucial?

• Use only the local language of the manufacture country
• Comply with destination country language, ingredient listing (INCI), and regulatory declarations
• Remove manufacturing date
• Use no symbols

Correct Answer: Comply with destination country language, ingredient listing (INCI), and regulatory declarations

Q19. Which warning is specifically important for ophthalmic (eye) preparations on the label?

• For external use only
• Do not refrigerate
• Shake vigorously before use
• For ophthalmic use only; avoid contamination of dropper tip

Correct Answer: For ophthalmic use only; avoid contamination of dropper tip

Q20. When labeling a product that contains known allergens (e.g., nuts or soy), the label must:

• List allergens prominently so sensitive individuals can avoid exposure
• Hide the allergens in fine print
• Replace allergen names with chemical codes
• Only inform retailers

Correct Answer: List allergens prominently so sensitive individuals can avoid exposure

Q21. What is a key difference in labeling requirements between OTC and prescription drugs?

• OTC labels need no active ingredient declaration
• Prescription labels appear on manufacturers only while OTC are pharmacist-applied
• Prescription drugs require prescriber information and directions on dispensing labels; OTC require comprehensive consumer directions and warnings on the product label
• OTC products do not require batch numbers

Correct Answer: Prescription drugs require prescriber information and directions on dispensing labels; OTC require comprehensive consumer directions and warnings on the product label

Q22. Which labeling control is critical during a label change in a pharmaceutical company?

• Immediate disposal of old labels without record
• Version control and documentation of approval, effective date, and distribution of revised labels
• Printing new labels without regulatory notification
• Using multiple fonts to differentiate

Correct Answer: Version control and documentation of approval, effective date, and distribution of revised labels

Q23. A “period-after-opening” (PAO) symbol on cosmetics indicates:

• The recommended period to use the product after opening for safety and quality
• The product shelf life before opening
• The product price validity
• Storage temperature

Correct Answer: The recommended period to use the product after opening for safety and quality

Q24. Which element is mandatory on the label of a hazardous drug to ensure safe handling?

• Manufacturer’s CEO name
• Appropriate hazard pictograms and handling precautions
• Marketing claims
• Customer testimonials

Correct Answer: Appropriate hazard pictograms and handling precautions

Q25. Why is the net quantity declaration required on both drug and cosmetic labels?

• To confuse consumers
• To state the amount of product provided for regulatory and consumer information
• To state the weight of the package only
• To satisfy tax authorities only

Correct Answer: To state the amount of product provided for regulatory and consumer information

Q26. For herbal cosmetic products, labeling should ideally include:

• Botanical (Latin) names of plant ingredients and parts used
• Only common names with no details
• Manufacturing plant photos
• Claims without substantiation

Correct Answer: Botanical (Latin) names of plant ingredients and parts used

Q27. Which practice reduces look‑alike/sound‑alike medication errors at the labeling stage?

• Using identical pack sizes for all products
• Implementing tall‑man lettering, distinct color coding, and clear strength display
• Removing generic names
• Using cursive fonts

Correct Answer: Implementing tall‑man lettering, distinct color coding, and clear strength display

Q28. “Keep in original container” instruction on a label is important because:

• Original containers are larger
• They often provide protection from light, moisture and include critical labeling information
• Original containers are cheaper
• It is a marketing phrase

Correct Answer: They often provide protection from light, moisture and include critical labeling information

Q29. Which information on a cosmetic label helps traceability during a recall?

• Promotional tagline
• Batch or lot number and manufacturing date
• Suggested retail outlets
• Designer logo

Correct Answer: Batch or lot number and manufacturing date

Q30. Which is an essential labeling requirement when a drug is intended for pediatric use?

• Use of adult dosing instructions only
• Clear pediatric dosing instructions, concentration, and appropriate warnings
• Omission of storage instructions
• Only the brand name

Correct Answer: Clear pediatric dosing instructions, concentration, and appropriate warnings

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com