FDA Label for Remedy Antifungal

View Indications, Usage & Precautions

Remedy Antifungal 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%


Purpose



Antifungal


Uses



  • 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 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 power over affected area twice a day (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • For athlete's foot, pay special attention between spaces in toes; wear well fitting, ventilated shoes, and change shoes and socks at least twice 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



Aphanizomenon Flos-Aquae (Algae) Extract, Camellia Sinensis (Green Tea) Leaf

Extract, Caprylic/Capric Triglycerides, 7-Dehydrocholesterol, Dipotassium Glycyrrhizate, Ethylene Brassylate, Eugenia Caryophyllus (Clove) Flower Extract, Glycerin, Hydrolyzed Soy Protein, Isopropyl Myristate, Methyldihydrojasmonate, Phospholipids, Silica, Sodium Benzoate, Tapioca Starch, Tocopheryl (Vitamin E) Acetate, Vanilla Plantifolia Fruit Extract, Water, Yeast Ferment Extract, Zea Mays (Corn) Oil, Zea Mays (Corn) Starch


Principal Display Panel



NDC 55329-169-79

Medline

Remedy®

Phytoplex®

Botanical Nutrition for Sensitive Skin

Treatment

Antifungal Powder

Miconazole Nitrate 2%

Helps treat & relieve

itching & burning

with a fungal infection

CHG Compatible

Paraben Free

Hypoallergenic

3.0 oz (85 g)


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