JOCK ITCH MICONAZOLE NITRATE- miconazole nitrate cream

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active Ingredient

Miconazole Nitrate USP, 2%

Purpose

Anti-fungal

Uses

• For the relief of symptoms associated with jock itch (tinea cruris).
• For effective relief of itching, burning, scaling, discomfort, and chafing associated with jock itch.

Warnings

• For external use only

Do not use

• on nails or scalp
• in or near the mouth or eyes
• for vaginal yeast infections

When using this product. avoid contact eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if too much irritation occurs or gets worse.

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

Directions

Adults and children 12 years and over:
Wash affected area and dry thoroughly.
Apply a thin layer over affected area twice daily (morning and night).
Supervise children in use of this product.
Use daily for 2 weeks.
If condition persists longer, ask a doctor.
This product is not effective on the scalp or nails.
Wash hands after each use.
Children under 12 years: ask a doctor.

Other Information

Do not use if seal on tube is broken or missing. Store at controlled room temperature 20–25°C (68–77°F).

Inactive ingredients

Organic Tea Tree Oil, Benzoic Acid, Cetyl Alcohol, Isopropyl Myristate, Polysorbate 60, Oxygenated Olive Oil, Potassium Hydroxide, Propylene Glycol, Purified Water, Stearyl Alcohol.

Product label

INGREDIENTS AND APPEARANCE

JOCK ITCH MICONAZOLE NITRATE 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83004-031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TEA TREE OIL (UNII: VIF565UC2G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CETYL ALCOHOL (UNII: 936JST6JCN)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYSORBATE 60 (UNII: CAL22UVI4M)
OLIVE OIL (UNII: 6UYK2W1W1E)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83004-031-01	1 in 1 BOX	01/14/2026
1		120 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	01/14/2026

Labeler - Rida LLC (004425803)