How To Be a Label Detective Protection Status

By Kathi Thimsen RN, MSN, WOCN

Over The Counter (OTC) Drug Labels

Understanding how to read the label of an over the counter (OTC) drug is essential for safe and effective use. Many skin and wound care products are FDA approved by compliance to a specific monograph relating to a particular product type.

Common OTC drugs used in skin and wound care include, but are not limited to, moisture barrier ointments and creams, cleansers, topical wound healing agents, and antifungal agents.

Knowing how to read and interpret a label becomes very important when prescribing treatments and interventions. Approved indications and uses, ingredients, and associated claims help the clinician provide the safest and most appropriate care. This approach also decreases the potential for provider liability, in the event that an adverse event or reaction results in litigation.

Over 1,000 medications now sold as OTC drugs were once dispensed by prescription only. Once found to be effective, safe, and not requiring medical supervision or oversight for use, the medications become available without a prescription. Being available OTC does not decrease the potency of a drug or guarantee its safety, according to the approved labeling information.

It is extremely prudent to become familiar with the important details listed on the label of OTC products that you are recommending. Even with no need for a prescription to obtain the medication, it is still a clinician’s responsibility and duty when recommending the product.

Important Sections of The OTC Label

Active Ingredient:

This is the first part of the label. The information discloses the product ingredient that is responsible for the primary treatment of a condition. Some products may list two active ingredients. Some ingredients may be listed and have different intended actions for two different products.


This may also be referred to as Indications. Uses guide the patient to identify what symptoms or conditions the medication can help.
This section will indicate if there is a potential complication or injury that can occur if the medication is used with other medications, treatments, foods or alcohol.
Warnings may also include directions for action in the event that the product is taken or used incorrectly, causing potential poisoning or toxicity.

Directions For Use:

This section indicates dosage - how much and how often to take or apply the drug.
Other Information:
This section of the label generally advises the user of special conditions/temperatures to store the product or how to maintain sterility.

Inactive Ingredients:

A section disclosing additional ingredients used in the product’s formulation. Information may include alcohol, color, fragrance, or dyes.

In Summary

While OTC medications can be safely used, they are still potent drugs that require a thorough label review, as well as discriminating use and recommendation.
It is our clinical responsibility to understand the formulation of these products, how ingredients are combined to provide specific actions to remedy a condition. Even if OTC products are regulated for safety, failure to properly interpret the labeling system could be detrimental to patient health. As clinicians, it is our duty to know!

About The Author
Kathi Thimsen RN, MSN, WOCN is a leader in the field of wound and ostomy care, publishing articles, presenting at conferences nationally and internationally, and serving on numerous committees and education boards including the International Association of Forensic Nurses Ethic Committee.

The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.

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