Ketoconazole 20 mg/mL Shampoo, Suspension, 120 mL
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Cortisol Synthesis Inhibitor class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Ketoconazole cream is used to treat tinea corporis (ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes), tinea versicolor (fungal infection of the skin that causes brown or light colored spots on the chest, back, arms, legs, or neck), and yeast infections of the skin. Prescription ketoconazole shampoo is used to treat tinea versicolor. Over-the-counter ketoconazole shampoo is used t...
Read the full MedlinePlus article ↗- Tinea versicolor is a fungal infection caused by a yeast that normally lives on everyone's skin. When it overgrows, it creates light or dark patches — most commonly on the chest, b...
- What exactly is tinea versicolor, and will this clear it up completely?
- The key is to never dispense it directly onto your hands — the foam starts melting the moment it hits warm skin. Instead, press the nozzle into the cap of the can or any cool surfa...
- How do I actually apply this foam without making a mess?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Ketoconazole — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 92005F972D
A foaming and thickening agent derived from coconut oil. It's used in liquid medicines to improve texture, help distribute active ingredients evenly, and create a pleasant consistency for easier swallowing or application.
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UNII D6DH1DTN7E
Disodium laureth sulfosuccinate is a synthetic surfactant and emulsifier derived from lauryl alcohol. It helps mix oil and water-based ingredients together and is commonly used in topical formulations to improve product texture and spreadability.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII M629807ATL
Imidazolidinyl urea is a synthetic preservative that prevents microbial growth in medicines. It's used in formulations to extend shelf life and maintain product safety during storage.
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UNII YM0K64F20V
A synthetic emulsifier derived from polyethylene glycol and glucose. It helps blend oil and water-based ingredients together and improves the texture and spreadability of the product.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII BPV390UAP0
Sodium laureth sulfate is a mild detergent and surfactant derived from coconut oil or petroleum. It helps mix oil and water in formulations and is often used as a cleaning or foaming agent in topical products like shampoos and cleansers.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
10 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.076 | $9.13 / 120 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.1585 | $19.02 / 120 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.1120 | $13.44 / 120 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ketoconazole 20 mg/mL 00713-0592-04 | Cosette | 120 ml | $0.076 | AB | Availability likely | — |
| Ketoconazole 20 mg/mL 45802-0465-64 | Padagis | 120 ml | $0.076 | AB | Availability likely | — |
| Ketoconazole 20 mg/mLthis 63646-0010-04 | TOLMAR | 120 ml | $0.076 | AB | Availability likely | — |
| Ketoconazole 20 mg/mL 70954-0662-10 | ANI | 120 ml | $0.076 | AB | Availability likely | — |
| Ketoconazole 20 mg/mL 72578-0156-12 | Viona | 120 ml | $0.076 | AB | Availability likely | — |
| Ketoconazole 20 mg/mL 72603-0878-01 | Northstar | 120 ml | $0.076 | AB | Availability likely | — |
| Ketoconazole 20 mg/mL 50090-3288-00 | A-S | 118.28 ml | — | AB | FDA listed | — |
| Ketoconazole 20 mg/mL 50090-7538-00 | A-S | 120 ml | — | AB | FDA listed | — |
| Ketoconazole 20 mg/mL 63629-8675-01 | Bryant | 120 ml | — | AB | FDA listed | — |
| Ketoconazole 20 mg/mL 68071-3930-04 | NuCare | 120 ml | — | AB | FDA listed | — |
| Ketoconazole 20 mg/mL 68071-5294-04 | NuCare | 120 ml | — | AB | FDA listed | — |
| Ketoconazole 20 mg/mL 68788-8257-01 | Preferred | 120 ml | — | AB | FDA listed | — |
| Ketoconazole 20 mg/mL 68788-8868-01 | Preferred | 120 ml | — | AB | FDA listed | — |
| Ketoconazole 20 mg/mL 70771-1874-07 | Zydus | 120 ml | — | AB | FDA listed | — |
| Ketoconazole 20 mg/mL 71205-0105-72 | Proficient | 120 ml | — | AB | FDA listed | — |
| Ketoconazole 20 mg/mL 71335-2839-01 | Bryant | 120 ml | — | AB | FDA listed | — |
| Ketoconazole 20 mg/mL 71713-0097-04 | THIRTY | 120 ml | — | AB | FDA listed | — |
| Ketoconazole 20 mg/mL 72162-1409-02 | Bryant | 120 ml | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63646-0010-04 You're viewing this | 120 mL in 1 BOTTLE, PLASTIC (63646-010-04) | 2005-04-11 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Ketoconazole shampoo, 2%, is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare ). Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites.
Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area. Lather, leave in place for 5 minutes, and then rinse off with water. One application of the shampoo should be sufficient.
⛔ Contraindications ▾
CONTRAINDICATIONS Ketoconazole shampoo, 2%, is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Clinical Trials Experience In 11 double-blind trials in 264 patients using ketoconazole shampoo, 2%, for the treatment of dandruff or seborrheic dermatitis, an increase in normal hair loss and irritation occurred in less than 1% of patients. In three open-label safety trials in which 41 patients shampooed 4-10 times weekly for six months, the following adverse experiences each occurred once: abnormal hair texture, scalp pustules, mild dryness of the skin, and itching. As with other shampoos, oiliness and dryness of hair and scalp have been reported.
In a double-blind, placebo-controlled trial in which patients with tinea versicolor were treated with either a single application of ketoconazole shampoo, 2%, (n=106), a daily application for three consecutive days (n=107), or placebo (n=105), drug-related adverse events occurred in 5 (5%), 7 (7%) and 4 (4%) of patients, respectively. The only events that occurred in more than one patient in any one of the three treatment groups were pruritus, application site reaction, and dry skin; none of these events occurred in more than 3% of the patients in any one of the three groups.
Post-marketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency. The following adverse drug reactions have been identified during post-marketing experience with ketoconazole shampoo, 2%: there have been reports of hair discoloration and abnormal hair texture, itching, skin burning sensation, contact dermatitis, hypersensitivity, angioedema, alopecia, rash, urticaria, skin irritation, dry skin, and application site reactions.
🤰 Pregnancy ▾
Pregnancy: Teratogenic effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In humans, ketoconazole is not detected in plasma after chronic shampooing on the scalp.
Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (a dose 10 times the maximum recommended human oral dose). However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels.
🧒 Pediatric Use ▾
Pediatric Use: Safety and effectiveness in children have not been established.
🆘 Overdosage ▾
OVERDOSAGE Ketoconazole shampoo, 2%, is intended for external use only. In the event of accidental ingestion, supportive and symptomatic measures should be employed. Induced emesis and gastric lavage should not be performed to avoid aspiration.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Tinea (pityriasis) versicolor is a non-contagious infection of the skin caused by Pityrosporum orbiculare (Malassezia furfur) . This commensal organism is part of the normal skin flora. In susceptible individuals the condition is often recurrent and may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs.
Treatment of the infection may not immediately result in restoration of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental skin exposure. The rate of recurrence of infection is variable.
Ketoconazole was not detected in plasma in 39 patients who shampooed 4-10 times per week for 6 months, or in 33 patients who shampooed 2-3 times per week for 3-26 months (mean: 16 months). An exaggerated use washing test on the sensitive antecubital skin of 10 subjects twice daily for five consecutive days showed that the irritancy potential of ketoconazole shampoo, 2%, was significantly less than that of 2.5% selenium sulfide shampoo. A human sensitization test, a phototoxicity study, and a photoallergy study conducted in 38 male and 22 female volunteers showed no contact sensitization of the delayed hypersensitivity type, no phototoxicity and no photoallergenic potential due to ketoconazole shampoo, 2%.
Mode of Action: Interpretations of in vivo studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes. It is postulated, but not proven, that the therapeutic effect of ketoconazole in tinea (pityriasis) versicolor is due to the reduction of Pityrosporum orbiculare (Malassezia furfur) and that the therapeutic effect in dandruff is due to the reduction of Pityrosporum ovale . Support for the therapeutic effect in tinea versicolor comes from a three-arm, parallel, double-blind, placebo controlled study in patients who had moderately severe tinea (pityriasis) versicolor.
Successful response rates in the primary efficacy population for each of both three-day and single-day regimens of ketoconazole shampoo, 2%, were statistically significantly greater (73% and 69%, respectively) than a placebo regimen (5%). There had been mycological confirmation of fungal disease in all cases at baseline. Mycological clearing rates were 84% and 78%, respectively, for the three-day and one-day regimens of the 2% shampoo and 11% in the placebo regimen.
While the differences in the rates of successful response between either of the two active treatments and placebo were statistically significant, the difference between the two active regimens was not. Microbiology: Ketoconazole is a broad spectrum synthetic antifungal agent which inhibits the growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: dermatophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floccosum; yeasts: Candida albicans, C. tropicalis, Pityrosporum ovale (Malassezia ovale) and Pityrosporum orbiculare (M. furfur) .
Development of resistance by these microorganisms to ketoconazole has not been reported.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ketoconazole Shampoo, 2%, is a red-orange liquid supplied in a 4-fluid ounce nonbreakable plastic bottle (NDC 63646-010-04). Storage conditions: Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature]. Protect from light. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Tolmar, Inc. Fort Collins, CO 80526 04006031 Rev. 2 11/22
📋 Description ▾
DESCRIPTION Ketoconazole shampoo, 2%, is a red-orange liquid for topical application, containing the broad spectrum synthetic antifungal agent ketoconazole in a concentration of 2% in an aqueous suspension. It also contains: sodium laureth sulfate, disodium laureth sulfosuccinate, cocamide diethanolamide, hydrochloric acid, PEG-120 methyl glucose dioleate, imidurea, sodium chloride, sodium hydroxide, fragrance, FD&C red No. 40, and purified water.
Ketoconazole is cis -1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1 H -imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula: chemical structure
💬 Information for Patients ▾
Information for Patients: Patients should be advised of the following: Ketoconazole shampoo, 2% may be irritating to mucous membranes of the eyes and contact with this area should be avoided. The following have been reported with the use of ketoconazole shampoo, 2%: hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, skin burning sensation and contact dermatitis, hypersensitivity, angioedema, alopecia, rash, urticaria, skin irritation, dry skin, and application site reactions.
Patients who develop allergic reactions, such as generalized rash, skin reactions, severe swelling, angioedema, or shortness of breath should discontinue ketoconazole shampoo, 2% and contact their physician immediately.