Remedy Antifungal Cream
FDA Label NDC 53329-162

14 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 Remedy Antifungal (NDC 53329-162). 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, use, 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

Active Ingredient

Miconazole Nitrate 2.0% w/w

Purpose

Antifungal

Use

  • 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

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 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 four weeks; for jock itch, use daily for two 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 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, PEG-6 stearate, PEG-8, PEG-32 stearate, polyisobutene, polysorbate 20, propanediol, propylene glycol, propylparaben, pyridoxine HCI, retinyl palmitate, silica, sorbitan isostearate, tocopherol, triethanolamine, water, zea mays oil

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