Search by Drug Name or NDC
NDC 21922-0025-04 Ketoconazole 20 mg/g Details
Ketoconazole 20 mg/g
Ketoconazole is a TOPICAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Encube Ethicals Private Limited. The primary component is KETOCONAZOLE.
MedlinePlus Drug Summary
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 to control flaking, scaling, and itching of the scalp caused by dandruff. Ketoconazole is in a class of antifungal medications called imidazoles. It works by slowing the growth of fungi that cause infection.
Related Packages: 21922-0025-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ketoconazole Topical
Product Information
| NDC | 21922-0025 |
|---|---|
| Product ID | 21922-025_c35038ef-b432-329e-e053-2a95a90a30f1 |
| Associated GPIs | 90154045003710 |
| GCN Sequence Number | 007334 |
| GCN Sequence Number Description | ketoconazole CREAM (G) 2 % TOPICAL |
| HIC3 | Q5F |
| HIC3 Description | TOPICAL ANTIFUNGALS |
| GCN | 31850 |
| HICL Sequence Number | 004132 |
| HICL Sequence Number Description | KETOCONAZOLE |
| Brand/Generic | Generic |
| Proprietary Name | Ketoconazole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ketoconazole Cream, 2% |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/g |
| Substance Name | KETOCONAZOLE |
| Labeler Name | Encube Ethicals Private Limited |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212443 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 21922-0025-04 (21922002504)
| NDC Package Code | 21922-025-04 |
|---|---|
| Billing NDC | 21922002504 |
| Package | 1 TUBE in 1 CARTON (21922-025-04) / 15 g in 1 TUBE |
| Marketing Start Date | 2021-05-27 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.25951 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | KETOCONAZOLE 2% CREAM |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 59188ef7-5bc9-4acc-bbff-8712c41e5f77 Details
DESCRIPTION
Ketoconazole Cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%. Each gram, for topical administration, contains ketoconazole 20 mg and is formulated in an aqueous cream vehicle consisting of propylene glycol, purified water, cetyl alcohol, stearyl alcohol, isopropyl myristate, sorbitan monostearate, polysorbate 60, polysorbate 80, and sodium sulfite, anhydrous:
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:
M. Formula: C 26H 28Cl 2N 4O 4 M.W.: 531.44
CLINICAL PHARMACOLOGY
When Ketoconazole Cream, 2% was applied dermally to intact or abraded skin of Beagle dogs for 28 consecutive days at a dose of 80 mg, there were no detectable plasma levels using an assay method having a lower detection limit of 2 ng/ml.
After a single topical application to the chest, back and arms of normal volunteers, systemic absorption of ketoconazole was not detected at the 5 ng/ml level in blood over a 72-hour period.
Two dermal irritancy studies, a human sensitization test, a phototoxicity study and a photoallergy study conducted in 38 male and 62 female volunteers showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity and no photoallergenic potential due to Ketoconazole Cream, 2%.
Microbiology:
Ketoconazole is a broad spectrum synthetic antifungal agent which inhibits the in vitro 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 , Malassezia ovale (Pityrosporum ovale) and
C. tropicalis; and the organism responsible for tinea versicolor,
Malassezia furfur (Pityrosporum orbiculare). Only those organisms listed in the INDICATIONS AND USAGE Section have been proven to be clinically affected. Development of resistance to ketoconazole has not been reported.
Mode of Action:
In vitro studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes. It is postulated that the therapeutic effect of ketoconazole in seborrheic dermatitis is due to the reduction of
M. ovale, but: this has not been proven.
INDICATIONS AND USAGE
Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); and in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.
CONTRAINDICATIONS
WARNINGS
Ketoconazole Cream, 2% is not for ophthalmic use.
Ketoconazole Cream, 2% contains sodium sulfite anhydrous, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
PRECAUTIONS
General
If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. Hepatitis (1:10,000 reported incidence) and, at high doses, lowered testosterone and ACTH induced corticosteroid serum levels have been seen with orally administered ketoconazole; these effects have not been seen with topical ketoconazole.
Carcinogenesis, Mutagenesis, Impairment of Fertility
A long-term feeding study in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity. The dominant lethal mutation test in male and female mice revealed that single oral doses of ketoconazole as high as 80 mg/kg produced no mutation in any stage of germ cell development. The Ames' Salmonella microsomal activator assay was also negative.
Pregnancy
Teratogenic effects
Pregnancy Category C
Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day, (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.
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.
Nursing Mothers
It is not known whether Ketoconazole Cream, 2% administered topically could result in sufficient systemic absorption to produce detectable quantities in breast milk. Nevertheless, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
ADVERSE REACTIONS
During clinical trials 45 (5%) of 905 patients treated with Ketoconazole Cream, 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. One of the patients treated with ketoconazole cream developed a painful allergic reaction.
In worldwide postmarketing experience, rare reports of contact dermatitis have been associated with ketoconazole cream or one of its excipients, namely sodium sulfite or propylene glycol.
To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch.
DOSAGE AND ADMINISTRATION
Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor: It is recommended that Ketoconazole Cream, 2% be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. Patients with tinea versicolor usually require two weeks of treatment . Patients with tinea pedis require six weeks of treatment.
If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.
Seborrheic dermatitis: Ketoconazole cream, 2% should be applied to the affected area twice daily for four weeks or until no clinical clearing. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.
HOW SUPPLIED
Ketoconazole Cream, 2% is supplied in 15, 30, and 60 gram tubes.
15 g tube (21922- 025-04)
30 g tube (21922- 025-05)
60 g tube (21922- 025-07)
STORAGE
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Mfg Lic No. : 361
Manufactured by :
Encube Ethicals Pvt. Ltd.
Plot No. C-1, Madkaim Industrial Estate,
Madkaim, Post: Mardol, Ponda,
Goa - 403 404, India.
Distributed by:
Encube Ethicals, Inc.
200 Meredith Avenue, Suite 101A
Durham, NC 27713 USA
Rev: 03
May 2021
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Ketoconazole Cream 2%, 15 g; Carton Text
KETOCONAZOLE CREAM 2%
21922-025-04
Rx only
15 g
FOR DERMATOLOGIC USE ONLY.
Ketoconazole Cream 2%, 15 g; Tube Label
KETOCONAZOLE CREAM 2%
21922-025-04
Rx only
15 g
FOR DERMATOLOGIC USE ONLY.
Ketoconazole Cream 2%, 30 g; Carton Text
KETOCONAZOLE CREAM 2%
21922-025-05
Rx only
30g
FOR DERMATOLOGIC USE ONLY.
Ketoconazole Cream 2%, 30 g; Tube Label
KETOCONAZOLE CREAM 2%
21922-025-05
Rx only
30g
FOR DERMATOLOGIC USE ONLY.
Ketoconazole Cream 2%, 60 g; Carton Text
KETOCONAZOLE CREAM 2%
21922-025-07
Rx only
60 g
FOR DERMATOLOGIC USE ONLY.
Ketoconazole Cream 2%, 60 g; Tube Label
KETOCONAZOLE CREAM 2%
21922-025-07
Rx only
60 g
FOR DERMATOLOGIC USE ONLY.
INGREDIENTS AND APPEARANCE
| KETOCONAZOLE
ketoconazole cream, 2% cream |
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
| Labeler - Encube Ethicals Private Limited (915834105) |
| Registrant - Encube Ethicals Private Limited (915834105) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Encube Ethicals Private Limited | 725076298 | analysis(21922-025) , label(21922-025) , manufacture(21922-025) , pack(21922-025) | |