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Miconazole Nitrate

Pronunciation

Class: Azoles
ATC Class: D01AC02
VA Class: DE102
CAS Number: 22832-87-7
Brands: Desenex, Femizol-M, Fungoid, Lotrimin AF, Micatin, Monistat, Ting, Vusion, Zeasorb-AF

Introduction

Antifungal; azole (imidazole derivative).a

Uses for Miconazole Nitrate

Dermatophytoses

Treatment of tinea corporis (body ringworm) and tinea cruris (jock itch) caused by Epidermophyton floccosum, Trichophyton mentagrophytes, or T. rubrum.a d h

Treatment of tinea pedis (athlete’s foot) caused by Epidermophyton floccosum, Trichophyton mentagrophytes, or T. rubrum.a d f g

Topical antifungals usually effective for treatment of uncomplicated tinea corporis or tinea cruris.104 105 106 108 An oral antifungal preferred when tinea corporis or tinea cruris is extensive, dermatophyte folliculitis is present, infection is chronic or does not respond to topical therapy, or patient is immunocompromised because of coexisting disease or concomitant therapy.104 105 106 108

Topical antifungals usually effective for treatment of uncomplicated tinea pedis.104 105 106 107 108 An oral antifungal may be necessary for treatment of hyperkeratotic areas on the palms and soles,105 108 for chronic moccasin-type (dry-type) tinea pedis,104 105 107 and for tinea unguium (fingernail or toenail dermatophyte infections, onychomycosis).104 105 106 107 108

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Pityriasis (Tinea) Versicolor

Treatment of pityriasis (tinea) versicolor caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).a

Topical treatment usually effective;104 105 107 110 111 112 an oral antifungal (alone or in conjunction with a topical antifungal) may be necessary in patients who have extensive or severe infections or who fail to respond to or have frequent relapses with topical therapy.107 110 111

Cutaneous Candidiasis

Treatment of cutaneous candidiasis caused by Candida albicans.a d

Treatment of candidal diaper dermatitis.b i Treatment of choice is a topical antifungal (e.g., nystatin, clotrimazole, miconazole).i Most infants with candidal diaper dermatitis harbor C. albicans in their intestines and infected feces appear to be an important source of the cutaneous infection.i Some clinicians recommend that an oral antifungal (e.g., oral nystatin) be administered concomitantly to treat the intestinal infection,i but studies have not provided evidence that concomitant oral and topical therapy is more effective than topical therapy alone.i

Vulvovaginal Candidiasis

Treatment of uncomplicated vulvovaginal candidiasis (mild to moderate, sporadic or infrequent, most likely caused by Candida albicans, occurring in immunocompetent women).100 102 113 114 115 118 119 135 j l m A drug of choice.100 102 113 114 115 118 119 135 j l m

Self-medication (OTC use) for treatment of uncomplicated vulvovaginal candidiasis in otherwise healthy, nonpregnant women who have been previously diagnosed by a clinician and are having a recurrence of similar symptoms.c e

Treatment of complicated vulvovaginal candidiasis, including infections that are recurrent (≥4 episodes in 1 year), severe (extensive vulvar erythema, edema, excoriation, fissure formation), caused by Candida other than C. albicans, or occurring in women with underlying medical conditions (uncontrolled diabetes mellitus, HIV infection, immunosuppressive therapy, pregnancy).100 k l Complicated infections generally require more prolonged treatment than uncomplicated infections.100 l k

Miconazole Nitrate Dosage and Administration

Administration

Administer topically to skin or intravaginally in appropriate formulations.a

Topical skin preparations are for external use only and should not be used orally, intravaginally, or near or in eyes or mucous membranes.a b

Intravaginal preparations are for intravaginal administration only and should not be used orally, topically on the skin, or near or in eyes.a

Topical Administration

Administer topically to the skin as a 0.25% ointment, 2% aerosol, 2% aerosol powder, or 2% cream, lotion, powder, or tincture.a

Do not use on the scalp or nails.a d e f g

Wash hands after applying.b

Shake sprays and lotions well before using.a g h f

Do not use tincture for self-medication in patients with diabetes, circulatory, renal, or hepatic problems.d

When treating dermatomycoses or cutaneous candidiasis, apply sparingly to cleansed, dry, infected area.a

When treating tinea pedis, pay special attention to spaces between toes.a d f g Also, wear well-fitting, ventilated shoes and change shoes and socks at least once daily.a d f g

When treating candidal diaper dermatitis, apply at each diaper change.b Gently cleanse skin with lukewarm water and pat dry with a soft towel.b Gently apply thin layer to diaper area with fingertips; do not rub into skin since this may cause additional irritation.b

Intravaginal Topical Administration

Administer intravaginally as a 2% cream or 100- or 200-mg suppository.a

Use for self-medication only in otherwise healthy, nonpregnant women with recurrent vulvovaginal candidiasis who were previously diagnosed by a clinician.100 c e

Dosage

Pediatric Patients

Dermatophytoses
Tinea Corporis or Tinea Cruris
Topical

Children ≥2–11 years of age: Apply twice daily (morning and evening) for 2 weeks.a d h

If clinical improvement does not occur after treatment, reevaluate the diagnosis.a

Tinea Pedis
Topical

Children ≥2–11 years of age: Apply twice daily (morning and evening) for 1 month.a d g

If clinical improvement does not occur after treatment, reevaluate the diagnosis.a

Pityriasis (Tinea) Versicolor
Topical

Children ≥2–11 years of age: Apply once daily for 2 weeks.a

If clinical improvement does not occur after 2 weeks of treatment, reevaluate the diagnosis.a

Cutaneous Candidiasis
Topical

Children ≥2–11 years of age: Apply twice daily (morning and evening) for 2 weeks.a d

If clinical improvement does not occur after treatment, reevaluate the diagnosis.a

Diaper Dermatitis
Topical

Infants ≥4 weeks of age: Apply to affected area at each diaper change for 7 days.b

Continue treatment for 7 days, even if improved.b

Ointment is not a substitute for frequent diaper changes;b do not use for prevention of diaper dermatitis.b (See Selection and Use of Antifungals for Diaper Dermatitis under Cautions.)

Uncomplicated Vulvovaginal Candidiasis
Intravaginal

Children ≥12 years of age: 100-mg suppository at bedtime for 7 days or 200-mg suppository at bedtime for 3 days.100 a Alternatively, applicatorful of 2% intravaginal cream once daily at bedtime for 7 days.100 a May be used for self-medication.100 a

If clinical symptoms do not improve within 3 days, persist for >7 days, or recur within 2 months, discontinue self-medicationand consult a clinician.a Confirm diagnosis and rule out other pathogens and conditions that may predispose a patient to recurrent vaginal fungal infections.100

Topical

For adjunctive relief of external vulvar itching: Apply 2% topical vulvar cream twice daily (morning and evening) for up to 7 days as needed.a e

HIV-infected Adolescents
Intravaginal

Use same regimen recommended for other patients.100 k Some experts recommend a duration of 3–7 days.k Maintenance regimen of an intravaginal azole can be considered for those with recurrent episodes;k routine primary or secondary prophylaxis (long-term suppressive or chronic maintenance therapy) not recommended.100 k

Complicated Vulvovaginal Candidiasis
Recurrent Vulvovaginal Infections Caused by Candida albicans
Intravaginal

Adolescents: CDC and others recommend an initial intensive regimen (7–14 days of an intravaginal azole or 3-dose regimen of oral fluconazole) to achieve mycologic remission, followed by an appropriate maintenance regimen (6-month regimen of once-weekly oral fluconazole or, alternatively, an intravaginal azole given intermittently).100 j l

Other Complicated Vulvovaginal Infections
Intravaginal

Adolescents: CDC and others recommend 7–14 days of an intravaginal azole for vulvovaginal candidiasis that is severe, caused by Candida other than C. albicans, or occurring in women with underlying medical conditions.100 l

Adults

Dermatophytoses
Tinea Corporis or Tinea Cruris
Topical

Apply twice daily (morning and evening) for 2 weeks.a d h

If clinical improvement does not occur after treatment, reevaluate the diagnosis.a

Tinea Pedis
Topical

Apply twice daily (morning and evening) for 1 month.a d g

If clinical improvement does not occur after treatment, reevaluate the diagnosis.a

Pityriasis (Tinea) Versicolor
Topical

Apply once daily for 2 weeks.a

If clinical improvement does not occur after treatment, reevaluate the diagnosis.a

Cutaneous Candidiasis
Topical

Apply twice daily (morning and evening) for 2 weeks.a

If clinical improvement does not occur after treatment, reevaluate the diagnosis.a

Uncomplicated Vulvovaginal Candidiasis
Intravaginal

100-mg suppository at bedtime for 7 days or 200-mg suppository at bedtime for 3 days.100 a Alternatively, applicatorful of 2% intravaginal cream once daily at bedtime for 7 days.100 a May be used for self-medication.100 a

If clinical symptoms do not improve within 3 days, persist for >7 days, or recur within 2 months, discontinue self-medicationand consult a clinician.a Confirm diagnosis and rule out other pathogens and conditions that may predispose a patient to recurrent vaginal fungal infections.100

Topical

For adjunctive relief of external vulvar itching: Apply 2% topical vulvar cream twice daily (morning and evening) for up to 7 days as needed.a e

HIV-Infected Adults
Intravaginal

Use same regimen recommended for other patients.100 k Some experts recommend a duration of 3–7 days.k Maintenance regimen of an intravaginal azole can be considered for those with recurrent episodes;k routine primary or secondary prophylaxis (long-term suppressive or chronic maintenance therapy) not recommended.100 k

Complicated Vulvovaginal Candidiasis
Recurrent Vulvovaginal Infections Caused by Candida albicans
Intravaginal

CDC and others recommend an initial intensive regimen (7–14 days of an intravaginal azole or 3-dose regimen of oral fluconazole) to achieve mycologic remission, followed by an appropriate maintenance regimen (6-month regimen of once-weekly oral fluconazole or, alternatively, an intravaginal azole given intermittently).100 j l

Other Complicated Vulvovaginal Infections
Intravaginal

CDC and others recommend 7–14 days of an intravaginal azole for vulvovaginal candidiasis that is severe, caused by Candida other than C. albicans, or occurring in women with underlying medical conditions.100 l

Pregnant women: CDC and others recommend a 7-day regimen of an intravaginal azole antifungal (e.g., miconazole).100 l

Prescribing Limits

Pediatric Patients

Diaper Dermatitis
Topical

Infants ≥4 weeks of age: Maximum treatment duration is 7 days; safety of longer treatment not known.b

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.a

Renal Impairment

No specific dosage recommendations at this time.a

Geriatric Patients

No specific dosage recommendations at this time.a

Cautions for Miconazole Nitrate

Contraindications

Known hypersensitivity to miconazole or any ingredient in the formulation.a b

Warnings/Precautions

Warnings

Use of Latex or Rubber Products

Miconazole vaginal suppositories contain petroleum base that can weaken latex or rubber products (including condoms and vaginal contraceptive diaphragms).a Concurrent use not recommended.a Consider use of miconazole vaginal cream as an alternative to the suppositories.a

Sensitivity Reactions

Hypersensitivity Reactions

Contact dermatitis reported following topical application of miconazole or other imidazole-derivative azole antifungals.125 126 127 128 129 130

If irritation or sensitivity occurs, discontinue the drug and contact a clinician.a

Possible cross-sensitization among the imidazoles.125 126 127 128 129 130 a

General Precautions

Selection and Use of Antifungals for Diaper Dermatitis

Prior to use of ointment for adjunctive treatment of diaper dermatitis, confirm diagnosis of candidiasis with microscopic evidence of pseudohyphae and/or budding yeast.b A positive fungal culture for C. albicans is not adequate evidence of candidal infection since colonization with C. albicans can result in a positive culture.b

Use ointment as part of a treatment regimen that includes measures directed at the underlying diaper dermatitis; the ointment is not a substitute for frequent diaper changes.b Do not use to prevent diaper dermatitis; preventive use may result in development of drug resistance.b

Safety and efficacy of ointment for treatment of diaper dermatitis in immunocompromised patients not established.b

Safety and efficacy of ointment have not been evaluated in incontinent adults; do not use in an attempt to prevent occurrence of diaper dermatitis (e.g., in adult institutional settings).b

Selection and Use of Antifungals for Vulvovaginal Candidiasis

Prior to initial use in a woman with signs and symptoms of vulvovaginal candidiasis, confirm the diagnosis by potassium hydroxide (KOH) microscopic mounts and/or cultures.100 102

Candida identified by culture in the absence of symptoms is not an indication for antifungal treatment since approximately 10–20% of women harbor Candida or other yeasts in the vagina.100

If clinical symptoms persist, repeat tests to rule out other pathogens, to confirm the original diagnosis, and to rule out other conditions that may predispose a patient to recurrent vaginal fungal infections.a

Do not use for self-medication in women who have never had a vaginal yeast infection diagnosed by a clinician,c e in women who are or think they may be pregnant, or in women with HIV infection or exposure.c e

Other Administration Precautions

Topical skin preparations are for external use only.a Do not administer orally or intravaginally.a Avoid contact with eyes, nose, mouth, and other mucous membranes.a

Intentional misuse by deliberately concentrating and inhaling the contents of the aerosols can be harmful or fatal.f g

Specific Populations

Pregnancy

Category C.b

CDC and others state that a 7-day regimen of an intravaginal azole antifungal can be used, if necessary, for treatment of vulvovaginal candidiasis in pregnant women.100 l

Lactation

Not known whether miconazole is distributed into milk; use with caution in nursing women.a b

Pediatric Use

Topical skin preparations: Use in children <2 years of age only if directed by a clinician.a d f g Use in children ≥2–11 years of age only under adult supervision.a

Ointment for candidal diaper dermatitis: Safety and efficacy not established in infants <4 weeks of age (premature or term) or very-low-birth weight infants.b (See Selection and Use of Antifungals for Diaper Dermatitis under Cautions.)

Intravaginal preparations: Safety and efficacy for self-medication not established in children <12 years of age.a e

Geriatric Use

Clinical studies evaluating miconazole ointment for treatment of candidal diaper dermatitis did not include any adults ≥65 years of age; safety and efficacy of the ointment have not been evaluated in geriatric adults.b

Common Adverse Effects

Irritation, burning, itching.a b

Interactions for Miconazole Nitrate

Weak inhibitor of CYP2C9.133 134

Drugs Metabolized by Hepatic Microsomal Enzymes

Drugs metabolized by CYP2C9: possible increased plasma concentrations.133 134

Specific Drugs

Drug

Interaction

Comments

Warfarin

Potential for increased plasma warfarin concentrations with intravaginal miconazole133 134

Potential for interaction with miconazole applied topically to skin is unknownb

Do not use intravaginal miconazole forself-medication if taking warfarin132 133 134 c

Miconazole Nitrate Pharmacokinetics

Absorption

Bioavailability

Minimal systemic absorption following topical application to skin.a b

Only small amounts absorbed systemically following intravaginal administration.a

Distribution

Extent

Not known whether systemically absorbed miconazole is distributed into milk.a

Elimination

Elimination Route

Following intravaginal administration, systemically absorbed drug excreted in urine and feces (1% of dose).a

Stability

Storage

Topical

Ointment

20–25°C (may be exposed to 15–30°C).b

Aerosol

2–30°C (Lotrimin AF);f 20–25°C (Desenex).g Do not use near fire or flame; do not expose to temperatures >49°C.f g

Aerosol Powder

2–30°C.h

Cream, Lotion, and Powder

Tight container at 15–30°C.a

Tincture

Protect from freezing; if crystals form, leave at room temperature for 2 days or immerse bottle in warm water for 6 hours until crystals dissolve, then shake well.d

Intravaginal

Cream

15–30°C.a

Suppository

20–25°C.e

Actions and Spectrum

  • Imidazole-derivative azole antifungal.a

  • Usually fungistatic in action; can be fungicidal at high concentrations or against very susceptible organisms (e.g., Candida).a

  • Presumably exerts its antifungal activity by altering cellular membranes, resulting in increased membrane permeability.a Interferes with ergosterol biosynthesis.b

  • Spectrum of antifungal activity includes many fungi, including yeasts and dermatophytes.a Also has in vitro activity against some gram-positive bacteria.a

  • Candida: Active against Candida albicans,a b C. guilliermondii,a and C. tropicalis.a

  • Dermatophytes and other fungi: Active against Epidermophyton floccosum, Microsporum canis, Trichophyton mentagrophytes, and T. rubrum.a

  • Bacteria: Active against Staphylococcus aureus.a

  • Cross-resistance can occur among the azole antifungals.

Advice to Patients

  • Topical Administration
  • Importance of completing full course of therapy, even if symptoms improve.d

  • Importance of contacting clinician if condition worsens during treatment or if improvement does not occur after completing full course of therapy.d

  • Importance of discontinuing use and consulting clinician if treated area becomes irritated (e.g., itching, burning, blistering, swelling, oozing).d

  • Importance of applying topical skin preparations to affected areas as directed and avoiding contact with eyes, nose, mouth, or mucous membranes.b d

  • Importance of washing hands after applying miconazole.b

  • Importance of consulting a clinician before using tincture if diagnosed with diabetes, circulatory, renal, or hepatic problems.d

  • For patients with tinea pedis (athlete’s foot), importance of wearing well-fitting, ventilated shoes and changing socks at least once daily.a d

  • For patients with candidal diaper dermatitis, importance of using ointment only for diaper dermatitis complicated by documented candidiasis.b Not for preventative use;b should not be used as a substitute for frequent diaper changes and should not be used long term.b

  • For patients with candidal diaper dermatitis, importance of gently cleansing diaper area with lukewarm water or a very mild soap and patting dry with a soft towel before applying ointment.b Importance of not rubbing ointment into skin since this may cause additional irritation.b

  • Importance of not using ointment on children for whom it is not prescribed.b

  • Intravaginal Administration
  • Importance of reading and understanding manufacturer’s patient instructions regarding use of applicator for intravaginal administration.c e

  • Not for self-medication in women who have never had a vaginal yeast infection diagnosed by a clinician.c e

  • Not for intravaginal self-medication in women who think they are pregnant or have been exposed to HIV, unless otherwise directed by a clinician.a c

  • Importance of discontinuing self-medication of vulvovaginal candidiasis and consulting clinician if rash or hives, fever, abdominal pain, foul-smelling vaginal discharge, or flu-like symptoms (fever, chills, nausea, vomiting) develop; if symptoms do not improve within 3 days, if condition persists beyond 7 days; or if symptoms recur within 2 months.c e

  • Importance of not using latex or rubber products such as condoms or vaginal contraceptive diaphragms within 72 hours following intravaginal miconazole treatment.a c

  • Importance of not douching after an intravaginal dose of miconazole.c

  • If used during menstruation, importance of using sanitary napkins instead of vaginal tampons.a c e

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and concomitant illnesses, including diabetes mellitus and HIV infection.a c

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.c

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Miconazole Nitrate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Aerosol

2%

Desenex Spray Liquid (with alcohol SD 40-B 15% w/w and dimethyl ether propellant)

Novartis

Lotrimin AF Athlete’s Foot Spray Liquid (with alcohol SD-40 17% w/w, propylene glycol, and isobutane propellant)

Schering-Plough

Micatin Athlete’s Foot Spray Liquid (with alcohol 17%, benzyl alcohol, and hydrocarbon propellants)

Pfizer

Aerosol Powder

2%

Desenex Jock Itch Spray Powder (with alcohol SD 40-B 10% w/w and isobutane/propane propellant)

Novartis

Desenex Athlete’s Foot Spray Powder (with alcohol SD 40-B 10% w/w and isobutane/propane propellant)

Novartis

Lotrimin AF Athlete’s Foot Deodorant Spray Powder (with alcohol SD 40-B 10% w/w, talc, and isobutane propellant)

Schering-Plough

Lotrimin AF Athlete’s Foot Spray Powder (with alcohol SD-40 10% w/w and isobutane propellant)

Schering-Plough

Lotrimin AF Jock Itch Spray Powder (with alcohol SD-40 10% w/w and isobutane propellant)

Schering-Plough

Micatin Athlete’s Foot Spray Powder (with alcohol 10% and hydrocarbon propellants)

Pfizer

Micatin Jock Itch Spray Powder (with alcohol 10% and hydrocarbon propellants)

Pfizer

Ting Antifungal Spray Powder (with alcohol SD 40-B 10% w/w and isobutane/propane propellant)

Insight

Cream

2%

Micatin Athlete’s Foot Cream

Pfizer

Micatin Jock Itch Cream

Pfizer

Miconazole Nitrate Cream

Actavis, Fougera, G&W, Taro

Monistat-Derm

Ortho Neutrogena

Lotion

2%

Zeasorb-AF Lotion (with alcohol 36% w/w)

Stiefel

Ointment

0.25%

Vusion Ointment (with zinc oxide and white petrolatum)

Barrier Therapeutics

Powder

2%

Desenex Athlete’s Foot Shake Powder

Novartis

Lotrimin AF Athlete’s Foot Powder (with talc)

Schering-Plough

Zeasorb-AF

Stiefel

Tincture

2%

Fungoid (with benzyl alcohol, glacial acetic acid, and isopropyl alcohol; with or without Nail Scrub and brush)

Pedinol

Vaginal

Cream

2%*

Femizol-M

Lake

Miconazole Nitrate Vaginal Cream

Actavis, Perrigo, Teva

Monistat 7

Personal Products

Kit

9 g Cream, topical, Miconazole Nitrate 2% (Monistat External Vulvar Cream)

7 Suppositories, vaginal, Miconazole Nitrate 100 mg (Monistat 7)

Monistat 7 Combination Pack

Personal Products

9 g Cream, topical, Miconazole Nitrate 2% (Monistat)

3 Suppositories, vaginal, Miconazole Nitrate 200 mg (Monistat 3)

Monistat 3 Combination Pack

Personal Products

9 g Cream, topical, Miconazole Nitrate 2% (Monistat External Vulvar Cream)

1 Suppositories, vaginal, Miconazole Nitrate 1200 mg (Monistat)

Monistat1 Combination Pack Dual-Pak

Personal Products

Suppositories

100 mg

Miconazole Nitrate Vaginal Suppository

Actavis, Perrigo

Monistat 7 (in a hydrogenated vegetable oil base)

Personal Products

200 mg

Miconazole Nitrate Vaginal Suppository

Actavis

Monistat 3 (in a hydrogenated vegetable oil base)

Personal Products

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Miconazole Nitrate 2% Cream (ACTAVIS MID ATLANTIC): 28/$12.99 or 56/$14.98

Monistat 3 200MG Suppositories (ORTHO-MCNEIL PHARMACEUTICAL): 3/$51.99 or 9/$147.96

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions August 1, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

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124. Reviewers’ comments (personal observations) on Tioconazole 84:04.08.

125. Bigardi AS, Pigatto PD, Altomare G. Allergic contact dermatitis due to sulconazole. Contact Dermatitis. 1992; 26:281-2. [PubMed 1395584]

126. Machet L, Vaillant L, Muller C et al. Contact dermatitis and cross-sensitivity from sulconazole nitrate. Contact Dermatitis. 1992; 26:352-3. [PubMed 1395603]

127. Jones SK, Kennedy CTC. Contact dermatitis from tioconazole. Contact Dermatitis. 1990; 22:122-3. [PubMed 2138969]

128. Baes H. Contact sensitivity to miconazole with ortho-chloro cross-sensitivity to other imidazoles. Contact Dermatitis. 1991; 24:89-93. [PubMed 1828223]

129. Marren P, Powell S. Contact sensitivity to tioconazole and other imidazoles. Contact Dermatitis. 1992; 27:129-30. [PubMed 1395626]

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