Fifthpulse Miconazole Nitrate Antifungal Ointment
FDA Label NDC 87525-004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wecare Products Llc for the product Fifthpulse Miconazole Nitrate Antifungal (NDC 87525-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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:

* Please review the disclaimer below.