Remedy Antifungal Cream
FDA Label NDC 53329-162

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 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, keep out of reach of children., directions, other information, 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%

Purpose

Antifungal

Use

  • For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • For the treatment of superficial skin infections caused by yeast (Candida albicans)
  • 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
  • avoid contact with the eyes
  • for athlete's foot and ringworm - if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor
  • for jock itch - if irritation occurs, or if there is no improvement within 2 weeks, discontinue use and consult 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 layer of 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 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 Ingredients

Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Leaf Juice, Apricot Kernel Oil PEG-6 Esters, Ascorbic Acid, Ascorbyl Palmitate, Cetyl Dimethicone, Cholecalciferol, Citric Acid, Citrus Aurantium Dulcis Peel Oil, Citrus Grandis Peel Oil, Citrus Tangerina Peel Oil, Diazolidinyl Urea, Glycine, Glycine Soja Oil, Glycol Stearate, Hydroxytyrosol, L-proline, L-taurine, Methylparaben, Methylsulfonylmethane, N-acetyl-L-cysteine, Niacinamide, Olea Europaea Fruit Oil, PEG-6 Stearate, PEG-8, PEG-32 Stearate, Polyisobutene, Polysorbate-20, Propanediol, Propylene Glycol, Propylparaben, Pyridoxine HCl, Retinyl Palmiate, Silica, Tocopherol, Triethanolamine, Vanillin, Water, Zea Mays Oil.

Principal Display Panel - Remedy

N 53329-162-04

MEDLINE

REMEDY

WITH OLIVAMINE

ANTIFUNGAL CREAM

TARGETED TREATMENT

Nourishes and helps relieve fungal symptoms of itching, burning and irritation.

NON-ALLERGENIC

NON-SENSITIZING

4 fl oz (118 mL)

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