FDA Label for Medline
View Indications, Usage & Precautions
Medline Product Label
The following document was submitted to the FDA by the labeler of this product Medline Industries, Lp. 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
Miconazole nitrate 2.0% w/w
Purpose
Antifungal
Uses
- for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
- 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
- on scalm or nails
When Using This Product
- avoid contact with eyes
Stop Use And Ask A Doctor If
- irritation occurs
- there is no improvement within 4 weeks for athlete's foot and ringworm
- 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 right away.
Directions
- clean the affected area and dry thoroughly
- apply a thin layer of ointment 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
Other Information
- protect from freezing
- avoid excessive heat
Inactive Ingredient
7-dehydrocholesterol, aphanizomenon flos-aquae (algae) extract, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, carboxymethyl cellulose, carthamus tinctorius (safflower) seed oil, dimethicone, eugenia caryophyllus (clove) flower extract, glycerin, hydrolyzed soy protein, olea europaea (olive) fruit oil, petrolatum, phospholipids, tocopheryl acetate, water, yeast ferment extract, zea mays (corn) oil
Manufacturing Information
Manufactured for:
Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
Made in the USA of domestic and imported materials
www.medline.com
1-800-MEDLINE (633-5463)
REF: MSC092625
V2 RH22PUA
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