Active Ingredient
Miconazole Nitrate 2%
Procure Antifungal Cream
FDA Label NDC 55681-047
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Twin Med Llc for the product Procure Antifungal (NDC 55681-047). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, stop using and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
Uses:
- Proven clinically effective in the treatment of most Athlete's foot, jock itch and ring worm
- Relieves itching, scaling, cracking and discomfort that can accompany these conditions
Warnings
Warnings
For external use only
Do Not Use
Do not use on children under 2 years of age unless directed by a doctor
When Using This Product
When using this product avoid contact with eyes
Stop Using And Ask A Doctor If
Stop using and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks (for athlete’s foot or ringworm) or 2 weeks (for jock itch)
Keep Out Of Reach Of Children
Keep out of reach of Children. In case of accidental ingestion, contact a physician or Poison Control Center right away.
Directions
Directions
- Cleanse affected area and dry thoroughly
- Apply thin layer to affected area twice daily (morning and night) or as directed by a physician
- Supervise children in the use of this product
- For athlete’s foot and ringworm, use daily for 4 weeks; for jock itch use daily for 2 weeks
- For athlete’s foot pay special attention to space between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
- This product is not effective on the scalp or nails
Inactive Ingredients
Inactive Ingredients: Cetostearyl Alcohol, Chlorocresol, Dibasic Sodium Phosphate, Edetate Disodium, Light Mineral Oil, Macrogol Cetostearyl Ether, Monobasic Sodium Phosphate Dihydrate, Propylene Glycol, Purified Water, White Petrolatum
* Please review the disclaimer below.
