Active Ingredient
Miconazole nitrate 2.0% w/w
Medline Cream
FDA Label NDC 53329-147
12 label sections · Submitted to the FDA by Medline Industries, Lp · 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 53329-147). 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, 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) or 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 doctor
When Using This Product
- avoid contact with the 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 over affected area twice daily or as directed by a physician
- supervise use by children
- 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 four weeks; for jock itch, use daily for two weeks
- if condition persists longer, consult a doctor
- this product is not effective on scalp or nails
Other Information
- protect from freezing
- avoid excessive heat
Inactive Ingredients
acrylamide/ammonium acrylate copolymer, aloe barbadensis leaf juice, apricot kernel oil PEG-6 esters, ascorbic acid, ascorbyl palmitate, cetyl dimethicone, cholecalciferol, citric acid, citrus aurantium dulcis (orange) peel oil, citrus grandis (grapefruit) peel oil, citrus tangerina (tangerine) peel oil, diazolidinyl urea, ethyl vanillin, glycine, glycine soja (soybean) oil, glycol stearate, hydroxytyrosol, l-proline, l-taurine, methylparaben, methylsulfonylmethane, n-acetyl-l-cysteine, niacinamide, olea europaea (olive) fruit oil, olea europaea (olive) leaf extract, PEG-6 stearate, PEG-8, PEG-32 stearate, polyisobutene, polysorbate 20, propanediol, propylene glycol, propylparaben, pyridoxine HCL, retinyl palmitate, silica, tocopherol, triethanolamine, vanillin, water, zea mays oil
Manufacturing Information
www.medline.com
©2022 Medline and Medline Remedy
are registered trademarks of
Medline Industries, LP.
Made in USA of foreign and domestic materials
Manufactured for Medline Industries, LP,
Three Lakes Drive, Northfield, IL 60093 USA
1-800-MEDLINE
REF: MSC092604
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