miconazole ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
systemic antifungal agents, miconazole derivatives 1800 22916-47-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • miconazole
  • miconazole nitrate
An imidazole antifungal agent that is used topically and by intravenous infusion.
  • Molecular weight: 416.12
  • Formula: C18H14Cl4N2O
  • CLOGP: 5.81
  • LIPINSKI: 1
  • HAC: 3
  • HDO: 0
  • TPSA: 27.05
  • ALOGS: -5.74
  • ROTB: 6

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.20 g O
1 g O
0.10 g V
1 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.00 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 144.18 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 25 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 7.14 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 9.48 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.08 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 19.75 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Jan. 8, 1974 FDA INSIGHT PHARMS
Dec. 30, 1985 PMDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
International normalised ratio increased 230.42 16.01 103 5710 46322 63436887
Drug interaction 183.63 16.01 158 5655 228973 63254236
Hydronephrosis 67.02 16.01 28 5785 10634 63472575
Cholestasis of pregnancy 58.57 16.01 15 5798 1210 63481999
Vulvovaginal burning sensation 46.18 16.01 14 5799 2095 63481114
Haemorrhage subcutaneous 45.38 16.01 15 5798 2968 63480241
Encephalitis fungal 44.34 16.01 7 5806 43 63483166
Haematuria 40.53 16.01 28 5785 29129 63454080
Cancer pain 40.42 16.01 14 5799 3191 63480018
Pericardial effusion 39.76 16.01 28 5785 30030 63453179
Sepsis neonatal 39.02 16.01 9 5804 467 63482742
Nail dystrophy 32.02 16.01 9 5804 1034 63482175
Neuropathy peripheral 29.94 16.01 44 5769 113623 63369586
Haematoma 29.72 16.01 25 5788 34795 63448414
Vulvovaginal pruritus 29.04 16.01 11 5802 3232 63479977
Drug ineffective 26.82 16.01 34 5779 1044731 62438478
Axillary pain 26.32 16.01 9 5804 1974 63481235
Lip swelling 25.88 16.01 22 5791 31041 63452168
Vulvovaginal candidiasis 25.68 16.01 10 5803 3165 63480044
Hypokalaemia 25.64 16.01 39 5774 103765 63379444
Vaginal erosion 24.88 16.01 4 5809 28 63483181
Vulvovaginal pain 23.49 16.01 9 5804 2726 63480483
Dry skin 22.68 16.01 27 5786 56860 63426349
Benign vulval neoplasm 22.24 16.01 4 5809 58 63483151
Premature labour 22.21 16.01 14 5799 12490 63470719
Catheter site haemorrhage 22.19 16.01 9 5804 3166 63480043
Drug withdrawal syndrome neonatal 22.10 16.01 8 5805 2073 63481136
Fungal sepsis 21.80 16.01 7 5806 1263 63481946
Fungal infection 20.79 16.01 21 5792 36853 63446356
Joint swelling 20.16 16.01 3 5810 327663 63155546
Jarisch-Herxheimer reaction 19.92 16.01 5 5808 372 63482837
Facial pain 19.20 16.01 12 5801 10549 63472660
Eosinophilia 18.72 16.01 16 5797 22740 63460469
Drug intolerance 18.59 16.01 3 5810 308658 63174551
Rash erythematous 18.31 16.01 21 5792 42489 63440720
Vulvovaginal swelling 18.03 16.01 5 5808 546 63482663
Pneumomediastinum 17.06 16.01 6 5807 1430 63481779
Appendicitis 16.62 16.01 10 5803 8219 63474990
Drug hypersensitivity 16.45 16.01 64 5749 310623 63172586
Retroperitoneal haematoma 16.14 16.01 7 5806 2906 63480303
Sepsis 16.01 16.01 40 5773 153083 63330126

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
International normalised ratio increased 169.69 18.87 84 3143 47243 34906461
Drug interaction 147.71 18.87 139 3088 225807 34727897
Coagulation time prolonged 29.98 18.87 9 3218 1293 34952411
Haematuria 28.97 18.87 29 3198 50037 34903667
Oedema genital 27.93 18.87 7 3220 513 34953191
Ocular myasthenia 27.74 18.87 6 3221 230 34953474
Genital rash 22.39 18.87 6 3221 572 34953132
Pharyngeal haematoma 21.72 18.87 4 3223 66 34953638
Haemorrhage subcutaneous 21.17 18.87 8 3219 2316 34951388

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
International normalised ratio increased 307.10 15.99 154 7572 84567 79652095
Drug interaction 242.47 15.99 246 7480 414937 79321725
Cholestasis of pregnancy 50.89 15.99 13 7713 980 79735682
Hydronephrosis 49.54 15.99 27 7699 17427 79719235
Haematuria 47.68 15.99 45 7681 68791 79667871
Cancer pain 39.72 15.99 16 7710 5229 79731433
Sepsis neonatal 35.85 15.99 6 7720 52 79736610
Nail dystrophy 31.77 15.99 9 7717 1004 79735658
Pericardial effusion 29.68 15.99 29 7697 46208 79690454
Hypokalaemia 27.85 15.99 50 7676 143990 79592672
Vulvovaginal candidiasis 27.40 15.99 10 7716 2504 79734158
Haematoma 26.74 15.99 29 7697 52166 79684496
Oedema genital 26.53 15.99 7 7719 599 79736063
Seizure 26.17 15.99 57 7669 188777 79547885
Drug withdrawal syndrome neonatal 25.95 15.99 6 7720 297 79736365
Dry skin 25.21 15.99 32 7694 67963 79668699
Axillary pain 25.11 15.99 9 7717 2140 79734522
Ocular myasthenia 24.49 15.99 6 7720 381 79736281
Premature labour 23.86 15.99 13 7713 8377 79728285
Coagulation time prolonged 23.80 15.99 9 7717 2486 79734176
Catheter site haemorrhage 23.60 15.99 11 7715 5106 79731556
Lip swelling 23.21 15.99 24 7702 40887 79695775
Benign vulval neoplasm 22.01 15.99 4 7722 58 79736604
Haemorrhage subcutaneous 21.14 15.99 10 7716 4799 79731863
Neuropathy peripheral 21.12 15.99 44 7682 141261 79595401
Urinary tract infection 20.68 15.99 66 7660 274446 79462216
Premature baby 20.19 15.99 9 7717 3771 79732891
Labelled drug-drug interaction medication error 18.98 15.99 18 7708 27632 79709030
Dementia 18.76 15.99 17 7709 24642 79712020
Pharyngeal haematoma 18.59 15.99 4 7722 142 79736520
Sepsis 17.82 15.99 62 7664 269366 79467296
Onychomadesis 17.39 15.99 9 7717 5233 79731429
Pneumomediastinum 17.27 15.99 8 7718 3659 79733003
Therapeutic agent-diagnostic test interaction 17.19 15.99 3 7723 34 79736628
Contusion 16.32 15.99 41 7685 148735 79587927
Eosinophilia 16.27 15.99 21 7705 45324 79691338
Vulvovaginal burning sensation 16.03 15.99 6 7720 1611 79735051

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A01AB09 ALIMENTARY TRACT AND METABOLISM
STOMATOLOGICAL PREPARATIONS
STOMATOLOGICAL PREPARATIONS
Antiinfectives and antiseptics for local oral treatment
ATC A07AC01 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
INTESTINAL ANTIINFECTIVES
Imidazole derivatives
ATC D01AC02 DERMATOLOGICALS
ANTIFUNGALS FOR DERMATOLOGICAL USE
ANTIFUNGALS FOR TOPICAL USE
Imidazole and triazole derivatives
ATC D01AC52 DERMATOLOGICALS
ANTIFUNGALS FOR DERMATOLOGICAL USE
ANTIFUNGALS FOR TOPICAL USE
Imidazole and triazole derivatives
ATC G01AF04 GENITO URINARY SYSTEM AND SEX HORMONES
GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
Imidazole derivatives
ATC J02AB01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIMYCOTICS FOR SYSTEMIC USE
ANTIMYCOTICS FOR SYSTEMIC USE
Imidazole derivatives
ATC S02AA13 SENSORY ORGANS
OTOLOGICALS
ANTIINFECTIVES
Antiinfectives
FDA CS M0002083 Azoles
FDA EPC N0000175487 Azole Antifungal
MeSH PA D058888 14-alpha Demethylase Inhibitors
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000935 Antifungal Agents
MeSH PA D065688 Cytochrome P-450 CYP2C9 Inhibitors
MeSH PA D065692 Cytochrome P-450 CYP3A Inhibitors
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D006727 Hormone Antagonists
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D065088 Steroid Synthesis Inhibitors
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:75282 ergosterol biosynthesis inhibitors
CHEBI has role CHEBI:82891 glucocorticoid receptor antagonists

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Tinea pedis indication 6020002 DOID:12403
Candidiasis of skin indication 49883006
Pityriasis versicolor indication 56454009 DOID:9060
Candidal vulvovaginitis indication 72605008 DOID:2272
Candidiasis of mouth indication 79740000 DOID:14262
Tinea corporis indication 84849002
Diaper rash indication 91487003
Tinea cruris indication 399029005
Onychomycosis due to dermatophyte indication 402134005
Deep mycosis indication 716203000
Oropharyngeal Candidiasis indication
Paronychia off-label use 71906005 DOID:13117
Disease of liver contraindication 235856003 DOID:409




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Cats Infections caused by Microsporum canis Indication
Cats Infections caused by Microsporum gypseum Indication
Cats Infections caused by Trichophyton mentagrophytes Indication
Dogs Infections caused by Microsporum canis Indication
Dogs Infections caused by Microsporum gypseum Indication
Dogs Infections caused by Trichophyton mentagrophytes Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Conofite Cream 2% Intervet Inc. 1
Conofite Lotion 1% Intervet Inc. 1
Surolan Elanco US Inc. 3
Easotic Virbac AH Inc. 3
Miconosol Med-Pharmex Inc. 1
Priconazole Lotion 1% and Spray 1% First Priority Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 6.49 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.25%;81.35%;15% VUSION MYLAN N021026 Feb. 16, 2006 RX OINTMENT TOPICAL 8147852 March 30, 2028 USE FOR TREATMENT OF DIAPER DERMATITIS COMPLICATED BY CANDIDIASIS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Beta-1 adrenergic receptor GPCR Ki 5.14 DRUG MATRIX
Prostaglandin G/H synthase 2 Enzyme IC50 4.59 DRUG MATRIX
Cannabinoid receptor 1 GPCR Ki 4.78 DRUG MATRIX
Mu-type opioid receptor GPCR Ki 5.61 DRUG MATRIX
D(1A) dopamine receptor GPCR Ki 5.51 DRUG MATRIX
D(2) dopamine receptor GPCR Ki 5.38 DRUG MATRIX
Adenosine receptor A2a GPCR Ki 5.10 DRUG MATRIX
Alpha-2A adrenergic receptor GPCR Ki 5.83 DRUG MATRIX
Potassium voltage-gated channel subfamily H member 2 Ion channel WOMBAT-PK
Cytochrome P450 3A4 Enzyme IC50 7 DRUG MATRIX
Sodium-dependent serotonin transporter Transporter Ki 6.38 DRUG MATRIX
Sodium-dependent noradrenaline transporter Transporter Ki 5.54 DRUG MATRIX
5-hydroxytryptamine receptor 1A GPCR Ki 5.18 DRUG MATRIX
5-hydroxytryptamine receptor 2A GPCR Ki 5.95 DRUG MATRIX
5-hydroxytryptamine receptor 2B GPCR Ki 5.45 DRUG MATRIX
5-hydroxytryptamine receptor 2C GPCR Ki 5.56 DRUG MATRIX
5-hydroxytryptamine receptor 6 GPCR Ki 5.30 DRUG MATRIX
Alpha-2B adrenergic receptor GPCR Ki 5.79 DRUG MATRIX
D(3) dopamine receptor GPCR Ki 5.96 DRUG MATRIX
Histamine H2 receptor GPCR Ki 5.18 DRUG MATRIX
Muscarinic acetylcholine receptor M1 GPCR Ki 6.02 DRUG MATRIX
Muscarinic acetylcholine receptor M2 GPCR Ki 5.81 DRUG MATRIX
Muscarinic acetylcholine receptor M3 GPCR Ki 6.18 DRUG MATRIX
Muscarinic acetylcholine receptor M4 GPCR Ki 6.35 DRUG MATRIX
Beta-3 adrenergic receptor GPCR Ki 5.39 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Ki 5.87 DRUG MATRIX
Cytochrome P450 2D6 Enzyme IC50 6 DRUG MATRIX
Adenosine receptor A1 GPCR Ki 5.14 DRUG MATRIX
Adenosine receptor A3 GPCR Ki 5.80 DRUG MATRIX
D(4) dopamine receptor GPCR Ki 5.27 DRUG MATRIX
Alpha-1D adrenergic receptor GPCR Ki 5.83 DRUG MATRIX
Kappa-type opioid receptor GPCR Ki 5.58 DRUG MATRIX
Delta-type opioid receptor GPCR Ki 5.92 DRUG MATRIX
Acetylcholinesterase Enzyme IC50 4.73 DRUG MATRIX
Cytochrome P450 2C9 Enzyme IC50 6.70 DRUG MATRIX
Aromatase Enzyme IC50 6.22 CHEMBL
Epidermal growth factor receptor Kinase IC50 4.53 DRUG MATRIX
Substance-P receptor GPCR Ki 5.43 DRUG MATRIX
Steroid 17-alpha-hydroxylase/17,20 lyase Enzyme Ki 6.61 CHEMBL
Cytochrome P450 2C19 Enzyme IC50 7.80 DRUG MATRIX
Alkaline phosphatase, tissue-nonspecific isozyme Enzyme EC50 4.15 CHEMBL
Tyrosine-protein kinase Fyn Kinase IC50 5.38 DRUG MATRIX
Receptor tyrosine-protein kinase erbB-2 Kinase IC50 4.56 DRUG MATRIX
Thromboxane-A synthase Enzyme IC50 6.58 DRUG MATRIX
Lanosterol 14-alpha demethylase Enzyme IC50 6.70 CHEMBL
Indoleamine 2,3-dioxygenase 1 Enzyme IC50 5.42 CHEMBL
Type-2 angiotensin II receptor GPCR Ki 5.11 DRUG MATRIX
Substance-K receptor GPCR Ki 5.79 DRUG MATRIX
Melanocortin receptor 4 GPCR Ki 4.92 DRUG MATRIX
Melanocortin receptor 5 GPCR Ki 4.67 DRUG MATRIX
Melanocortin receptor 3 GPCR Ki 4.79 DRUG MATRIX
Malate dehydrogenase cytoplasmic Enzyme IC50 4.60 CHEMBL
Calcium release-activated calcium channel protein 1 Ion channel IC50 4.57 CHEMBL
7-alpha-hydroxycholest-4-en-3-one 12-alpha-hydroxylase Enzyme IC50 5.82 CHEMBL
Lanosterol 14-alpha demethylase Enzyme INHIBITOR CHEMBL CHEMBL
Beta-lactamase Enzyme IC50 4.40 CHEMBL
Androgen receptor Transcription factor Ki 5.33 DRUG MATRIX
5-hydroxytryptamine receptor 1B GPCR Ki 5.03 DRUG MATRIX
Membrane-associated progesterone receptor component 1 Membrane receptor Ki 5.69 DRUG MATRIX
Progesterone receptor Transcription factor Ki 5.71 DRUG MATRIX
5-hydroxytryptamine receptor 1A GPCR IC50 4.94 CHEMBL
Acetylcholinesterase Enzyme IC50 4.67 CHEMBL
Aromatase Enzyme EC50 6.40 CHEMBL
Cholinesterase Enzyme IC50 5.17 CHEMBL
Lanosterol 14-alpha demethylase Enzyme Kd 6.70 CHEMBL
Indoleamine 2,3-dioxygenase 2 Enzyme IC50 5.17 CHEMBL
Mycocyclosin synthase Enzyme Kd 7.14 CHEMBL
Indoleamine 2,3-dioxygenase 1 Enzyme IC50 4.75 CHEMBL
Fatty acid hydroperoxide lyase, chloroplastic Enzyme IC50 4.19 CHEMBL
Sodium/potassium-transporting ATPase subunit alpha-2 Ion channel IC50 4.72 DRUG MATRIX

External reference:

IDSource
4018555 VUID
N0000146875 NUI
D00416 KEGG_DRUG
22832-87-7 SECONDARY_CAS_RN
4018554 VANDF
4018555 VANDF
C0025942 UMLSCUI
CHEBI:6923 CHEBI
CHEMBL91 ChEMBL_ID
CHEMBL1559 ChEMBL_ID
D008825 MESH_DESCRIPTOR_UI
DB01110 DRUGBANK_ID
4189 PUBCHEM_CID
2449 IUPHAR_LIGAND_ID
2728 INN_ID
7NNO0D7S5M UNII
42790 RXNORM
1135 MMSL
36502 MMSL
5112 MMSL
5113 MMSL
7143 MMSL
d00155 MMSL
002918 NDDF
002919 NDDF
372738006 SNOMEDCT_US
42720001 SNOMEDCT_US
60727003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Good Sense Miconazole 7 HUMAN OTC DRUG LABEL 1 0113-0214 CREAM 2 g VAGINAL ANDA 17 sections
good sense miconazole 7 HUMAN OTC DRUG LABEL 1 0113-0825 CREAM 2 g VAGINAL ANDA 17 sections
basic care miconazole 3 HUMAN OTC DRUG LABEL 1 0113-7070 CREAM 40 mg VAGINAL ANDA 17 sections
basic care miconazole 7 HUMAN OTC DRUG LABEL 1 0113-7825 CREAM 2 g VAGINAL ANDA 17 sections
Selan Antifungal HUMAN OTC DRUG LABEL 1 0159-2500 CREAM 2 g TOPICAL OTC monograph final 12 sections
Selan Antifungal HUMAN OTC DRUG LABEL 1 0159-2500 CREAM 2 g TOPICAL OTC monograph final 12 sections
Desenex HUMAN OTC DRUG LABEL 1 0316-0225 POWDER 20 mg TOPICAL OTC monograph final 13 sections
Zeasorb HUMAN OTC DRUG LABEL 1 0316-0231 POWDER 20 mg TOPICAL OTC monograph final 12 sections
Zeasorb HUMAN OTC DRUG LABEL 1 0316-0232 POWDER 20 mg TOPICAL OTC monograph final 12 sections
Athletes Foot HUMAN OTC DRUG LABEL 1 0363-0557 SPRAY 2 g TOPICAL OTC monograph final 13 sections
Miconazole 7 HUMAN OTC DRUG LABEL 1 0363-0730 CREAM 20 mg VAGINAL ANDA 17 sections
Miconazole 7 HUMAN OTC DRUG LABEL 1 0363-0730 CREAM 20 mg VAGINAL ANDA 17 sections
Jock Itch HUMAN OTC DRUG LABEL 1 0363-1497 SPRAY 2 g TOPICAL OTC monograph final 13 sections
miconazole 3 HUMAN OTC DRUG LABEL 1 0363-2070 CREAM 40 mg VAGINAL ANDA 17 sections
Miconazole Nitrate HUMAN OTC DRUG LABEL 1 0363-3115 POWDER 1.42 g TOPICAL OTC monograph final 13 sections
Miconazole Nitrate HUMAN OTC DRUG LABEL 1 0363-3115 POWDER 1.42 g TOPICAL OTC monograph final 13 sections
Miconazole Nitrate HUMAN OTC DRUG LABEL 1 0363-4208 SPRAY 3 g TOPICAL OTC monograph final 13 sections
Miconazole Nitrate HUMAN OTC DRUG LABEL 1 0363-4208 SPRAY 3 g TOPICAL OTC monograph final 13 sections
Miconazole Nitrate 2% HUMAN OTC DRUG LABEL 1 0363-5353 AEROSOL, SPRAY 1.30 g TOPICAL OTC monograph final 14 sections
Miconazole Nitrate 2% HUMAN OTC DRUG LABEL 1 0363-5353 AEROSOL, SPRAY 1.30 g TOPICAL OTC monograph final 14 sections
Miconazole Nitrate HUMAN OTC DRUG LABEL 1 0363-7418 AEROSOL, SPRAY 2.60 g TOPICAL OTC monograph final 13 sections
Miconazole Nitrate HUMAN OTC DRUG LABEL 1 0363-7418 AEROSOL, SPRAY 2.60 g TOPICAL OTC monograph final 13 sections
VUSION HUMAN PRESCRIPTION DRUG LABEL 3 0378-8222 OINTMENT 2.50 mg TOPICAL NDA authorized generic 26 sections
VUSION HUMAN PRESCRIPTION DRUG LABEL 3 0378-9730 OINTMENT 2.50 mg TOPICAL NDA 26 sections
Miconazole 7 HUMAN OTC DRUG LABEL 1 0472-0730 CREAM 20 mg VAGINAL ANDA 17 sections
Antifungal HUMAN OTC DRUG LABEL 1 0472-0735 CREAM 20 mg TOPICAL OTC monograph final 13 sections
Antifungal HUMAN OTC DRUG LABEL 1 0472-0735 CREAM 20 mg TOPICAL OTC monograph final 13 sections
Miconazole 7 HUMAN OTC DRUG LABEL 1 0472-1736 SUPPOSITORY 100 mg VAGINAL ANDA 17 sections
Miconazole Nitrate HUMAN PRESCRIPTION DRUG LABEL 1 0472-1738 SUPPOSITORY 200 mg VAGINAL ANDA 16 sections
Miconazole Nitrate HUMAN OTC DRUG LABEL 1 0536-1134 CREAM 20 mg TOPICAL OTC MONOGRAPH FINAL 14 sections