FDA Label for Miconazole Nitrate
View Indications, Usage & Precautions
Miconazole Nitrate Product Label
The following document was submitted to the FDA by the labeler of this product Allied Trade Link 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.
Uses
For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) Relieves itching, scaling, burning, discomfort
and chafing associated with jock itch or itching, burning feet
Warnings For External Use Only
Do not use On children under 2 years of age unless directed by a doctor For diaper rash.
When using this product Avoid contact with the eyes
Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no
improvement within 4 weeks when used for athlete's foot and ringworm
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Miconazole Nitrate 2%
For External Use Only
Do not use On children under 2 years of age unless directed by a doctor For diaper rash.
When using this product Avoid contact with the eyes
Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no
improvement within 4 weeks when used for athlete's foot and ringworm
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Do Not Use
Do not use On children under 2 years of age unless directed by a
doctor For diaper rash.
When using this product Avoid contact with the eyes
Stop Use And Ask A Doctor If
Stop use and ask a doctor if Irritation occurs There is no
improvement within 2 weeks when used for the treatment of jock
itch There is no improvement within 4 weeks when used for athlete's
foot and ringworm
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.
Other Information
Do not use if seal on the tube is damaged or
is not visible. To open, unscrew cap, pull tab to remove foil seal See
crimp of tube or carton for Lot Number and Expiry Date Preserve in
well-closed containers, and store controlled room temperature
Inactive Ingredients
Inactive Ingredients Cetostearyl Alcohol, Chlorocresol, Edetate
Disodium, Light Mineral Oil, Macrogol Cetostearyl Ether, Propylene
Glycol, Purified Water, Sodium Phosphate Dibasic Dihydrate, Sodium
Phosphate Monobasic Dihydrate, White Petrolatum
Active Ingrediant
Miconazole Nitrate 2%
Directions And Uses
Uses
For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) Relieves itching, scaling, burning, discomfort
and chafing associated with jock itch or itching, burning feet
Clean the affected area and dry thoroughly Apply a thin layer of the 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 the toes; wear well-fitting,
ventilated shoes, and change shoes and socks at least once daily 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 the scalp or nails
Purposde
Miconazole Nitrate 2% ........................................................................................................................................................................................................................................................................... Antifungal
Package Label.Principal Display Panel
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