FIFTHPULSE MICONAZOLE NITRATE ANTIFUNGAL- miconazole nitrate ointment

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active ingredients

Miconazole Nitrate 2%

Purpose

Anti-Fungal

Uses

• Proven clinically effective in the treatment of most athlete's foot (tinea pedis) , jock itch (tinea cruris), and ringworm (tinea corporis)
• Relieves itching, scaling, cracking, burning and discomfort associated with these conditions.

Warnings

For external use only.

Do not use 

if the safety-sealed tube is punctured or damaged.

Do not useon children 2 years of age unless directed by a doctor.

When using this product

avoid contact with eyes.

Stop use and ask 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).
• Irritation occurs, or if there is no improvement within 2 weeks (for jock itch).

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor. Supervise children in the use of this product. For athelete's foot:Pay special attention to the spaces between the toes; Wear well-fitting ventilated shoes Change socks at least once daily.
For ringworm:Use daily for 4 weeks. If condition persists, consult a doctor.
For jock itch:Use daily for 2 weeks. If condition persists longer, consult a doctor.  This product is not effective on the scalp or nails.

Other information:

Store at 15° to 30° C (59° to 86°F)  Lot number and expiration date see crimp of tube or see box. To open: Unscrew cap, tear safety seal off.

Inactive ingredients

Alcohol, Carbomer, Cetostearyl alcohol, Dimethyl sulfoxide, Edetate disodium, Ethylparaben, Glycerol, Mineral oil, Mono-and-di-glycerides, Petrolatum, Polyoxyethylene lauryl ether, Purified water, Stearic acid, Triethanolamine.

Questions or Comments?

Please call 1-888-209-5201

Package Labeling:

Package Labeling:

INGREDIENTS AND APPEARANCE

FIFTHPULSE MICONAZOLE NITRATE ANTIFUNGAL 
miconazole nitrate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87525-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87525-004-01	1 in 1 BOX	04/30/2026
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 87525-004-02	1 in 1 BOX	04/30/2026
2		113.4 g in 1 TUBE; 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	04/30/2026

Labeler - WeCare Products LLC (085508446)

Registrant - WeCare Products LLC (085508446)