Ketoconazole Shampoo

Ketoconazole Shampoo

Ketoconazole Shampoo Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


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.


There is currently no drug history available for this drug.

Other Information

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: coconut fatty acid diethanolamide, disodium laureth sulfosuccinate, FD & C Red No. 40, hydrochloric acid, imidurea, laurdimonium hydroxypropyl hydrolyzed collagen, PEG-120 methyl glucose dioleate, purified water, sodium chloride, sodium hydroxide, and sodium lauryl ether sulfate.

Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula:

image of chemical structure

Ketoconazole Shampoo Manufacturers

  • Physicians Total Care, Inc.
    Ketoconazole Shampoo, Suspension [Physicians Total Care, Inc.]
  • Patriot Pharmaceuticals, Llc
    Ketoconazole Shampoo [Patriot Pharmaceuticals, Llc]
  • Sandoz Inc.
    Ketoconazole Shampoo, Suspension [Sandoz Inc.]
  • Aidarex Pharmaceuticals Llc
    Ketoconazole Shampoo, Suspension [Aidarex Pharmaceuticals Llc]
  • Preferred Pharmaceuticals, Inc.
    Ketoconazole Shampoo, Suspension [Preferred Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Ketoconazole Shampoo, Suspension [Preferred Pharmaceuticals, Inc.]
  • Perrigo New York Inc
    Ketoconazole Shampoo, Suspension [Perrigo New York Inc]

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