Label: REMEDY ANTIFUNGAL WITH OLIVAMINE- miconazole nitrate cream

  • NDC Code(s): 53329-162-04
  • Packager: Medline Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated November 6, 2019

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  • 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

    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, water.

  • SPL UNCLASSIFIED SECTION

    Medline Remedy is a registered trademark of Medline Industries, Inc. Olivamine is a registered trademark of McCord Research, Inc. Manufactured in USA for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA.
    www.medline.com 1-800-MEDLINE RJ18WAR

  • Principal Display Panel - Remedy

    Label 118 mL

  • INGREDIENTS AND APPEARANCE
    REMEDY ANTIFUNGAL  WITH OLIVAMINE
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-162
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    VANILLIN (UNII: CHI530446X)  
    WATER (UNII: 059QF0KO0R)  
    CORN OIL (UNII: 8470G57WFM)  
    TAURINE (UNII: 1EQV5MLY3D)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PEG-6 STEARATE (UNII: 8LQC57C6B0)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
    MANDARIN OIL (UNII: NJO720F72R)  
    HYDROXYTYROSOL (UNII: QEU0NE4O90)  
    APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
    PEG-32 STEARATE (UNII: 33GX5WQC0M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCINE (UNII: TE7660XO1C)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-162-04113 g in 1 TUBE; Type 0: Not a Combination Product01/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/2007
    Labeler - Medline Industries, Inc. (025460908)