MICONAZOLE NITRATE- antifungal cream

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by McKesson, Central Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Miconazole Nitrate 2%

PURPOSE

Purpose

Antifungal

INDICATIONS & USAGE

Uses

Treats most jock itch, ringworm and athlete’s foot

WARNINGS

Warnings

Do not use

• on children under 2 years of age
• for diaper rash.

For external use only.

Avoid contact with eyes.

STOP USE

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

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

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

Other Information

• This product is not effective on scalp or nails.
• Store at 59-86ºF (15-30ºC).

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

NDC: 68599-1471-4

McKesson
Antifungal Cream 2%
MICONAZOLE
NITRATE

Relieves itching, cracking, scaling and
discomfort associated with most jock itch,
ringworm and athlete’s foot.

4 fl oz
(118.3 mL)

MFR # 53-6391

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
antifungal cream

Product 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	100 mg  in 2 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)