Label: DERMASANA- miconazole nitrate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 55992-023-01 - Packager: OMG Medical Group, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 1, 2013
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Warnings
do not used on children under two years of age except under the advice and supervision of a doctor
stop use and ask a doctor if irritation occurs, if conditions worsens, or there is not improvement within four weeks.
for external use only
avoid contact with eyes, scalp, vagina, penis, scrotum and anus
do not ingest
do not use on open wounds
in case of accidental ingestion contact a physician, emergency medical
do not use if you are known to be sensitive to any of the ingredients in this product
- active ingredient
- purpose
- KEEP OUT OF REACH OF CHILDREN
- directions
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uses
antifungal drying agent
antibacterial drying agent
is indicated in the treatment of most fungi
athlete's foot (tinea pedis)
ringworm (tinea corporis)
jock itch (tinea cruris)
candida albicans
trichophyton rubrum
malassezia furfur
trichophyton mentagrophytes
epidemophyton floccsum
is indicated for the treatment of most bacteria
gram positive bacteria (such as staphyloocccous aureus)
is indicated for certain methicillin resistant saphylococcus aureus (MRSA) isolates
is indicated for most coagulase-negative staphylococci
beta hemolytic streptococci
corynebacterium species
clostridium species
anaerobic gram-negative bacilli (such as bacteriodes fragilis)
- other information
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DERMASANA
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55992-023 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 200 mg in 1 mg TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 30 mg in 1 mg Inactive Ingredients Ingredient Name Strength ACETIC ACID (UNII: Q40Q9N063P) WATER (UNII: 059QF0KO0R) BENZYL ALCOHOL (UNII: LKG8494WBH) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) LAURETH-7 (UNII: Z95S6G8201) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55992-023-01 200 mg in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 02/14/2013 Labeler - OMG Medical Group, LLC (038837214) Establishment Name Address ID/FEI Business Operations OMG Medical Group, LLC 038837214 repack(55992-023) Establishment Name Address ID/FEI Business Operations Pure Source 969241041 manufacture(55992-023)
