Ketoconazole
Antifungal. Sold as Nizoral A-D shampoo.
Ketoconazole shampoo is an antifungal product sold over the counter for dandruff. It is often mentioned as part of a hair care routine alongside treatments that are approved for hair loss, but its own label makes no claim about hair regrowth.
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | Status for this use | Supply | Label version |
|---|---|---|---|
| Nizoral A-D shampooKramer Laboratories | Approved for another condition | Over the counter | 17 March 2026 |
How it works
Written by us
Ketoconazole is an antifungal. The over-the-counter Drug Facts label states the purpose of the product as an anti-dandruff shampoo and describes what it controls: flaking, scaling and itching associated with dandruff.
What this product is for
The approved uses, as worded in the label.
From the FDA label
Uses controls flaking, scaling and itching associated with dandruff
Active ingredient
The presentations and strengths listed in the label.
From the FDA label
Active ingredient Purpose Ketoconazole 1% w/w Anti-dandruff shampoo
Directions
What the label states about administration. It is not a dosing instruction for any individual.
From the FDA label
- wet hair thoroughly
- apply shampoo, generously lather, rinse thoroughly. Repeat
- use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed to control dandruff
- ask a doctor
Stop use and ask a doctor if
The adverse reactions the label reports as most common.
From the FDA label
- rash appears
- condition worsens or does not improve in 2-4 weeks
Warnings
The warnings and precautions section of the label.
From the FDA label
- avoid contact with eyes
- if product gets into eyes, rinse thoroughly with water
Do not use
Situations in which the label states the medication must not be used.
From the FDA label
- on scalp that is broken or inflamed
- if you are allergic to ingredients in this product
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
From the FDA label
If pregnant or breast-feeding, ask a doctor before use.
Generic or brand
Written by us
Generic ketoconazole shampoo is approved and available, both over the counter at 1 percent and by prescription at higher strength.
The FDA label database lists 14 approved generic applications for this ingredient.
What affects the cost
Written by us
This is an over-the-counter product with many approved generics. This site does not track prices and does not link to sellers.
Common questions
- Does ketoconazole shampoo regrow hair?
- Its FDA label makes no such claim. The label states that the product controls flaking, scaling and itching associated with dandruff. Any other use is outside what the regulator reviewed.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Nizoral A-D shampoo
Kramer Laboratories. Label version 7, effective 17 March 2026.
Page last updated: 29 July 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.