Remedy Antifungal Targeted Treatment

Dosage form: powder
Ingredients: Miconazole Nitrate 20mg in 1g
Labeler: Medline Industries, Inc.
NDC Code: 53329-170

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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 powder 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 ingredients

Aloe Barbadensis Leaf Juice, Corn Starch/Acrylamide/Sodium Acrylate Copolymer, Citrus Aurantium Dulcis Peel Oil, Citrus Grandis Peel Oil, Citrus Tangerina Peel Oil, Glycine, Hydroxytyrosol, L-proline, L-taurine, Methylparaben, Methylsulfonylmethane, N-acetyl-L-cysteine, Niacinamide, Pyridoxine HCl, Silica, Vanillin.

Questions

1-800-MEDLINE

Principal Display Panel

N 53329-170-79

MEDLINE

REMEDY

WITH OLIVAMINE

ANTIFUNGAL

POWDER

TARGETED TREATMENT

Super absorbent talc-free formula that helps relieve fungal symptoms of itching, burning and irritation.

NON-ALLERGENIC

NON-SENSITIZING

Net Wt. 3 oz (85 g)

REMEDY ANTIFUNGAL  TARGETED TREATMENT
miconazole nitrate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-170
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole) Miconazole Nitrate20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Aloe Vera Leaf 
Glycine 
Methylparaben 
Dimethyl Sulfone 
Niacinamide 
Pyridoxine 
Silicon Dioxide 
Vanillin 
Packaging
#Item CodePackage Description
1NDC:53329-170-7985 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/2007
Labeler - Medline Industries, Inc. (025460908)

Revised: 03/2012
 
Medline Industries, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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