Is lanolin a drug?

What is lanolin?

Lanolin is a fatty substance obtained from sheep's wool. It is used as an emollient, meaning a skin softening ingredient, in cosmetics and pharmaceutical preparations. You can find it in moisturizers, makeup and medicated creams. Being part of a medicine does not necessarily mean lanolin is the ingredient responsible for that medicine's treatment effect.14

When does a lanolin product count as a drug?

A moisturizer intended to soften skin or improve its appearance can be a cosmetic. A product intended to treat or prevent disease, or affect the body's structure or function, meets the legal definition of a drug. Intended use can come from packaging, advertising, website claims, consumer expectations and ingredients with recognized therapeutic uses. A moisturizer can be a cosmetic and a drug, so the bathroom shelf is not obliged to pick a department.3

What should you look for on the label?

Look at lanolin's listed role and the product's stated uses, not just its name. For example, McKesson Skin Protectant Cream with Lanolin is a nonprescription drug containing 50% lanolin as its active ingredient. Its purpose is skin protection, and its uses include helping prevent irritation and protecting chafed skin or minor irritation due to incontinence. That classification applies to this cream; it does not turn every lanolin moisturizer into a medicine.2

How do you use a lanolin skin protectant?

For the McKesson 50% lanolin cream, follow these label directions:

1. 1Gently cleanse the affected area.
2. 2Dry the area.
3. 3Apply the cream liberally as needed.

Use this cream externally and keep it out of the eyes. Do not use it on deep or puncture wounds, animal bites or serious burns. Stop using it and ask a doctor if the condition lasts more than seven days. That is a limit for seeking medical advice, not a promise that the cream will resolve irritation within a week. Other lanolin products need their own directions.2

Who should be careful with lanolin?

Lanolin can cause irritation or allergic contact dermatitis, an allergic skin reaction where the product touches skin. People with existing dermatitis or damaged skin appear more likely to become sensitized. Signs include itching, redness, swelling or blistering hours to days after application. An allergic reaction can develop even after a product was previously well tolerated. Redness can be harder to see on darker skin, so itching and swelling also matter.4

If lanolin causes a reaction, stop using the product. A clinician can investigate suspected allergy with patch testing. Once lanolin allergy is identified, avoid lanolin and check labels for related names, including wool alcohols, wool fat, wool wax and anhydrous lanolin. Symptoms usually settle after the allergen or irritant is avoided; continued exposure can cause lasting symptoms.4

Lanolin can be harmful if swallowed. Seek medical help promptly after ingestion, and do not induce vomiting unless poison control or a healthcare professional tells you to. In the United States, call Poison Help at 800 222 1222. Trouble breathing or swelling of the mouth or throat needs emergency help.5

Does drug status mean FDA approval?

Not necessarily. Drugs generally need individual FDA approval or must comply with an applicable nonprescription drug monograph, a set of rules for that drug category. Cosmetics generally do not need FDA approval before sale, except for color additives. The term 'cosmeceutical' has no legal meaning in the United States, however much work it does on a carton.3