FDA Label for Anti-fungal
View Indications, Usage & Precautions
Anti-fungal Product Label
The following document was submitted to the FDA by the labeler of this product Universal Distribution Center Llc. 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.
Otc - Active Ingredient
Active Ingredient
Miconazole Nitrate 2%
Otc - Purpose
Purpose
Antifungal
Indications & Usage
Uses
- cures most athlete's foot, jock itch, and ringworm.
- relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.
Warnings
Warnings
Do not use on children under 2 years of age except under the advice and supervision of a doctor.
For external use only.
Otc - When Using
When using this product avoid contact with eyes.
Otc - Stop Use
Stop using this product and ask a doctor
- irritation occurs
- there is no improvement within 4 weeks (for athlete’s foot and ringworm) or 2 weeks (for jock itch).
- do not use for diaper rash
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
wash affected area and dry thoroughly
Apply a thin layer 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 the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day
for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
if conditions persist longer, ask a doctor
this product is not effective on the scalp or nails.
Other
Other information
- Store between 20°C to 25° C (68°F to 77° F)
- Lot No. & Exp. Date: see crimp of tube.
Inactive Ingredient
Inactive Ingredients
Purified water, cetostearyl alcohol, cetomacrogol-1000, mineral oil, petrolatum, propyleneglycol, sodium phosphate, chlorocresol.
Package Label.Principal Display Panel
PRINCIPAL DISPLAY PANEL
Anti-Fungal Cream
NET WT 0.5 OZ (14 g)
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