Label: ANTIFUNGAL- miconazole nitrate cream
- NDC Code(s): 68599-1470-4
- Packager: McKesson
- Category: HUMAN OTC DRUG LABEL
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.
Updated October 19, 2017
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Miconazole Nitrate 2%Close
- INDICATIONS & USAGE
Treats most jock itch, ringworm and athlete’s footClose
WarningsDo not use
- on children under 2 years of age
- for diaper rash. For external use only.
Avoid contact with eyes.
If irritation occurs or if there is no improvement within 4Close
weeks for athlete’s foot or ringworm, or within 2 weeks
for jock itch, discontinue use and consult a doctor.
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed, get medicalClose
help or contact a Poison Control Center right away.
- DOSAGE & ADMINISTRATION
- 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.
- 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
- use daily for 2 weeks. If condition persists longer, consult a doctor.
This product is not effective on scalp or nails.Close
- STORAGE AND HANDLING
Other information Store at 59-86ºF (15-30ºC).Close
- INACTIVE INGREDIENT
Inactive ingredients Purified Water, Isopropyl Palmitate, Glycerin, Glyceryl Stearate, PEG 100 Stearate, Cetearyl Alcohol,Close
Cyclopentasiloxane, Propylene Glycol, Polyquaternium-37, Dicaprylate/Dicaprate, PPG-1 Trideceth-6, Aloe Barbadensis Leaf
Juice, DMDM Hydantoin, Iodopropynyl Butylcarbamate, (may contain Lactic Acid).
- SPL UNCLASSIFIED SECTION
Questions? Call 1-800-777-4908Close
- PRINCIPAL DISPLAY PANEL
2% Miconazole Nitrate
Relieves itching, cracking, scaling and discomfort associated with most jock itch, ringworm and athlete’s foot.
4 fl oz
- INGREDIENTS AND APPEARANCE
miconazole nitrate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68599-1470 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 mL Inactive Ingredients Ingredient Name Strength IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN) PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA) PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q) ALOE (UNII: V5VD430YW9) DMDM HYDANTOIN (UNII: BYR0546TOW) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) GLYCINE (UNII: TE7660XO1C) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68599-1470-4 118 mL in 1 TUBE; Type 0: Not a Combination Product 05/26/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 05/26/2017 Labeler - McKesson (023904428) Establishment Name Address ID/FEI Business Operations Central Solutions 007118524 manufacture(68599-1470)