FDA Label for Antifungal Cream
View Indications, Usage & Precautions
Antifungal Cream Product Label
The following document was submitted to the FDA by the labeler of this product Bluepoint Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Active Ingredient Purpose
Miconazole Nitrate 2% Antifungal
Purpose
- For the treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
- For the treatment of superficial skin infections caused by Yeast (Candida Albicans)
- Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch.
Warnings
For external use only
Do not use:
- on children under 2 years of age unless directed by a doctor.
- avoid contact with eyes
- for athlete's foot and ringworm- if irritation occurs, or if there is no improvement within 4 weeks, discotinue use and consult a doctor
- for jock itch- if irritation occurs, or if there is no improvement within 2 weeks, discontinue use and consult a doctor.
- for diaper rash
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Indications And Usage
- Clean the affected area and dry thoroughly. Apply a thin layer of cream over affected area twice daily (morning and night) or as directed by a doctor.
- Supervise children in the use of this product.
- For athlete's foot: Pay special attention to spaces between toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
Dosage And Administration
- For athlete's foot and ringworm, use daily for 4 weeks.
- For jock itch, use daily for 2 weeks.
- If condition persists longer, consult a doctor.
- This product is not effective on scalp or nails.
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.
Inactive Ingredients
Inactive Ingredients: Cetomacrogol 1000, Cetostearyl alcohol, Chlorocresol,Liquid paraffin, Propylene glycol, Purified water, White soft paraben
Otc - Questions
Contact 1-800-707-4621
Storage And Handling
- Store at 15 0 to 30℃ ( 59 0 to 86 0 F)
- Preserve in thight containers
2% Miconazole Nitrate Cream, Usp Carton
2 % Miconazole Nitrate Cream, Usp Tube Label
* Please review the disclaimer below.