Ketoconazole
Antifungal
- Nizoral A-D shampoo
- Dandruffnot hair loss
Nizoral A-D shampoo
Each stripe is one section of the label, each division in a stripe one entry in that section.
Reference information, not medical advice
This page is a reference, not medical advice. It reports what the FDA-approved label states and links to that label. It does not tell anyone what to take, and it cannot replace a conversation with a doctor or pharmacist who knows the person's history.
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 | What its label approves | Supply | Label version |
|---|---|---|---|
| Nizoral A-D shampooKramer Laboratories | DandruffNot hair loss | Over the counter | 17 March 2026 |
How it works
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.
Uses controls flaking, scaling and itching associated with dandruff
Active ingredient
The presentations and strengths listed in the 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.
- 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.
- rash appears
- condition worsens or does not improve in 2-4 weeks
Warnings
The warnings and precautions section of the 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.
- 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.
If pregnant or breast-feeding, ask a doctor before use.
Generic or brand
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 13 approved generic applications for this ingredient.
What affects the cost
This is an over-the-counter product with many approved generics. This site sells nothing and links to no sellers.
What pharmacies pay for it
These are acquisition costs: what pharmacies in the United States pay on average to buy the medication, published weekly by the Centers for Medicare and Medicaid Services. They are not retail prices and not what a person pays at the counter, which depends on insurance, pharmacy and discount programmes. They are useful as an objective floor and for seeing how far a brand sits above its generic.
| Measured | Generic |
|---|---|
| per gram | $0.271 (range $0.163 to $6.39, 577 listings) |
| per millilitre | $0.080 (range $0.077 to $0.084, 177 listings) |
| per tablet, capsule or pen | $0.651 (range $0.631 to $0.693, 156 listings) |
Median of 910 listings. Effective dates 2025-12-17 to 2026-07-22, file dated 2026-07-29.
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.
Other medications under hair loss
Whether each one carries an FDA approval for this use is marked on its page and in this list.
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: 16 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.