Ketoconazole 20 mg/g
Ketoconazole Cream, 2% · CREAM · Sportpharm LLC
Ketoconazole is a cream containing ketoconazole cream, 2% at 20 mg/g, taken topical. Manufactured by Sportpharm LLC.
Key Facts
- Brand Name
- Ketoconazole
- Generic Name
- Ketoconazole Cream, 2%
- NDC Code (Product)
85766-135- Manufacturer
- Sportpharm LLC
- Strength
- 20 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA212443
- Drug Class
- Azole Antifungal [EPC]
- Marketing Start
- 05/27/2021
Recall History
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
Tolmar, Inc.
Subpotent
American Pharmaceutical Ingredients LLC
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
Fougera Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Fougera Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
ALMIRALL, LLC
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS & 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 & Administration
DOSAGE & 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 react…
Frequently Asked Questions
What is Ketoconazole used for?
Ketoconazole contains Ketoconazole Cream, 2%. It is a cream taken topical. Consult your doctor for specific uses.
Is Ketoconazole a controlled substance?
Ketoconazole is not classified as a controlled substance by the DEA.
What is the generic name for Ketoconazole?
The generic name for Ketoconazole is Ketoconazole Cream, 2%. There are no other listed brand versions of Ketoconazole Cream, 2%.
What is the NDC code for Ketoconazole 20 mg/g?
The NDC (National Drug Code) for Ketoconazole 20 mg/g is 85766-135, listed by Sportpharm LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)