Label: MICONAZOLE NITRATE- antifungal cream
- NDC Code(s): 68599-1471-4
- Packager: McKesson
- 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 September 13, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- Clean the affected area and dry thoroughly.
- Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician.
- Supervise children in the use of this product.
Athlete’s foot
- Pay special attention to the spaces between toes
- wear well-fitting, ventilated shoes and change shoes and socks at least once daily
Athlete’s foot and ringworm
- use daily for 4 weeks
Jock Itch
- use daily for 2 weeks.
If condition persists longer, consult a doctor.
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, BHT, Cetyl Alcohol, Dimethicone,
DMDM Hydantoin, Glycerin, Glyceryl Stearate, Isopropyl Palmitate, PEG 100 Stearate,Iodopropynyl Butylcarbamate,Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine (may contain Citric Acid).
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE
antifungal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68599-1471 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 mg in 100 mg Inactive Ingredients Ingredient Name Strength DMDM HYDANTOIN (UNII: BYR0546TOW) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) PEG-100 STEARATE (UNII: YD01N1999R) STEARIC ACID (UNII: 4ELV7Z65AP) ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) TROLAMINE (UNII: 9O3K93S3TK) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68599-1471-4 118 mg in 1 TUBE; Type 0: Not a Combination Product 07/25/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 07/25/2019 Labeler - McKesson (023904428) Establishment Name Address ID/FEI Business Operations Central Solutions 007118524 manufacture(68599-1471)
