This document discusses guidelines for label requirements of topical applications. It provides information on the topical route of drug administration and common topical dosage forms. It also describes the different types of labels, including manufacturer labels and dispensing labels. The document outlines general guidelines for labeling pharmaceutical and healthcare products, such as displaying important product information, formatting labels for FDA approval, choosing approved materials, and controlling label quality. It discusses specific labeling requirements for different drug formulations, like ophthalmic, cosmetic, aerosol, and cream products. Legal requirements for drug labeling are also presented.

1. Course Title: Industrial Pharmacy I
Course Code: BP502T
Course Instructor: Rakesh Kumar Sharma
Submitted By: Yash Tyagi
Roll No.: RY1801B49
Reg. No.: 11814149

2. TERM PAPER TOPIC
GUIDELINES FOR
LABEL REQUIREMENTS OF TOPICAL
APPLICATIONS

3. TOPICAL ROUTE OF
DRUG ADMINISTRATION
Defined as the application of a drug containing
formulation to the skin or mucous membrane, to treat
specific cutaneous disorders (e.g. acne) or cutaneous
manifestations of a generalized disease (e.g. psoriasis),
with the intent of containing the pharmacological
effect of the drug only to the surface or within the
layers of skin or mucous membrane.

4. TOPICAL DOSAGE FORMS
SOLID: Powder, Aerosol, Plaster
LIQUID: Lotion, Liniment,
Solution, Emulsion, Suspension,
Aerosol
SEMI-SOLID: Ointment, Cream,
Paste, Gel, Jelly, Suppository

5. LABELS
Label means a display of written, printed or
graphic matter upon immediate container or
the wrapper of a drug package.

6. TYPES OF LABELS
• MANUFACTURER LABEL
A label which contain drug information for
the use of medical practitioners,
pharmacists, or nurses supplied by the
manufacturer, packer, or distributor of the
drug.
• DISPENSING LABEL
It is defined as the label used for
dispensing, bearing the name and address
of the supplier, the nature of the medicine
and any other prescribed directions, the
name of patient and the date of
dispensing.

7. GENERAL GUIDELINES FOR LABELING
PHARMACEUTICALAND HEALTHCARE PRODUCTS
One of the main responsibilities of the food and drug administration (FDA) is regulating the
labeling standards for pharmaceutical, medical, nutraceutical, and dietary products. All
pharmaceutical and healthcare products must be labeled correctly for consumer safety.
1. Labeling responsibilities
• According to the FDA, all labels printed for use in the pharmaceutical and healthcare
industry are required to be designed and applied so they can remain in place and be read in
different environments through distribution, storage, and use.
• The label manufacturer is responsible for making sure that the print is legible and will remain
that way throughout the product’s lifespan. Product manufacturers are responsible for
complying with content and format requirements.

8. 2. Displaying product information
All types of labeling have content requirements for what types of information and claims can
be stated on a label. Each drug and medical device classification has their own set of
requirements for what information should be shown on the product. Several important things
to include on a pharmaceutical or healthcare product label:
• Official product name
• Active and inactive ingredients
• Drug facts table
• Purpose and use
• Warnings
• Directions
• Allergic reactions

9. 3. Formatting labels for FDA approval
Your labels must be designed in the appropriate FDA format for your product’s classification
like OTC medications, oral contraceptives, combination products, etc. Some things you should
consider when designing labels for FDA approval:
• Font size and type (must be legible)
• Language (appropriate use of abbreviations, grammar, advertised claims, etc.)
• Format (organization and appearance of sections like drug facts, warnings, uses, etc.)
• Materials (depending on the nature of the product)
4. Choosing approved materials
• Label materials for pharmaceuticals aren’t as stringently regulated as the packaging/container
that will touch the drug product. The label materials can be made from standard white paper
stock to holographic films to shrink sleeve labels, depending on what you want the label to
do.
• Multi-layer labels are often used because pharmaceutical and healthcare products are
required to share large amounts of information.

10. 5. Controlling label quality
Every label printed should be inspected thoroughly to ensure the information is consistent and
accurate. Industry standards must be met for safety and liability reasons which is why it’s
important to discuss with your label manufacturer their quality control processes
• Printing multiple pharmaceutical labels: the products should be separated to prevent any
mix-ups or switches. Product separation can be physical or spatial or can be completed by
performing press runs at different times to avoid confusion. Ask your label manufacturer
whether the areas around the presses are completely cleared from previous print jobs – this
provides less room for any printing errors.
• Proper control of storage: an important consideration, proper storage control is necessary
for preventing any mix-ups or switches when dealing with labels printed for use in the
pharmaceutical industry. After your labels have run and before they are issued for use, you
should carefully examine them to ensure they comply with your specifications and FDA
standards.

11. LEGAL REQUIREMENTS FOR LABELING OF DRUGS
All finished drug products should be identified by labelling, as required by the national legislation, bearing at least
the following information:
• The name of the drug product;
• A list of the active ingredients (if applicable, with the international nonproprietary names), showing the amount
of each present, and a statement of the net contents, e.g. Number of dosage units, weight or volume;
• the batch number assigned by the manufacturer;
• the expiry date in an uncoded form;
• any special storage conditions or handling precautions that may be necessary;
• directions for use, and warnings and precautions that may be necessary; and
• the name and address of the manufacturer or the company or the person responsible for placing the product on
the market.

12. SPECIAL REQUIREMENTS IN LABELING
1. For Ophthalmic solution/suspension/ointment
• Use within one month after opening the container.
• For ophthalmic use only
• Not for injection
• Name & concentration of preservatives if used.
• Special instructions regarding storage wherever applicable.
• Warning: if irritation persist or increases, discontinue the
use & consult the physician.
• Do not touch the dropper tip or other dispensing tip to any
surface since this may contaminate the solutions.

13. 2. For Cosmetics
• On both inner & outer label it should indicate
o name of the cosmetic
o the name & address of the manufacturer
• On the outer label, it should indicate the net content of the package. Such statement need not appear on the
label if the net content does not exceeds 60 ml/30 grams
• On the inner label, it should indicate, the proper direction of safe use, warning, caution, or the ‘special
direction’ & the names & contents of ingredients that are poisons or hazardous.
• The label in addition should indicate
o batch no., Only if the content of cosmetics is more than 10 gm or 25 ml, in case of soap instead of batch no. The
month & year of manufacture of soap shall be given on the label.
o Mfg. lic. no. Preceded by letter M.
• If the package or container of the cosmetic has only one label, it should contain all the information required
to be shown on both inner & outer label.

15. 3. For Aerosols inhalations
• pressurized containers keep away from heat
source
• shake before use
• do not exceed the prescribed dose
4. For Creams
• for external use only
• store in cool place

16. REFERENCES
• https://www.Makingcosmetics.Com/labeling-of-cosmetics_ep_67.Html?Locale=en
• https://www.Slideshare.Net/kir2n/pharmaceutical-labelling-46661344?From_action=save
• https://www.Slideshare.Net/anilpethe/pharma-lables
• https://consolidatedlabel.Com/label-articles/guidelines-labeling-pharmaceutical-healthcare-
products/
• https://www.fda.gov/cosmetics/cosmetics-labeling-regulations/summary-cosmetics-labeling-
requirements
• https://www.melbourne.vic.gov.au/SiteCollectionDocuments/labelling-requirements.pdf