United States - English - NLM (National Library of Medicine)
MICONAZOLE NITRATE- antifungal cream
McKes s on
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.
Miconazole Nitrate 2%
Treats most jock itch, ringworm and athlete’s foot
Do not use
on children under 2 years of age
for diaper rash.
For external use only.
Avoid contact with eyes.
Consult a Doctor
If irritation occurs or if there is no improvement within 4 weeks for athlete’s foot or ringworm,
or within 2 weeks for jock itch.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
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
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.
Store at 59-86ºF (15-30ºC).
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, BHT, Cetyl Alcohol,
DMDM Hydantoin, Glycerin, Glyceryl Stearate, Isopropyl Palmitate, PEG 100 Stearate,Iodopropynyl
Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine (may contain Citric Acid).
Antifungal Cream 2%
Relieves itching, cracking, scaling and
discomfort associated with most jock itch,
ringworm and athlete’s foot.
4 fl oz
MFR # 53-6391
Product T ype
HUMAN OTC DRUG
Ite m Code (Source )
NDC:6 8 59 9 -1471
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
Stre ng th
MICO NAZO LE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0 D7S5M)
10 0 mg in 2 mg
Stre ng th
DMDM HYDANTO IN (UNII: BYR0 546 TOW)
GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)
ISO PRO PYL PALMITATE (UNII: 8 CRQ2TH6 3M)
PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)
STEARIC ACID (UNII: 4ELV7Z6 5AP)
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
CARBO MER CO PO LYMER TYPE A ( ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: 71DD5V9 9 5L)
BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)
CETYL ALCO HO L (UNII: 9 36 JST6 JCN)
GLYCERIN (UNII: PDC6 A3C0 OX)
WATER (UNII: 0 59 QF0 KO0 R)
DIMETHICO NE (UNII: 9 2RU3N3Y1O)
TRO LAMINE (UNII: 9 O3K9 3S3TK)
IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)
Marketing Start Date
Marketing End Date
NDC:6 8 59 9 -1471-4
118 mg in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct
0 7/25/20 19
Marke ting Cate gory
Application Numbe r or Monograph Citation
Marke ting Start Date
Marke ting End Date
OTC mo no graph final
0 7/25/20 19