Active Ingredient
Miconazole nitrate 2.0% w/w
Medline Ointment
FDA Label NDC 53329-172
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Medline (NDC 53329-172). 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 use 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
- 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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