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Remedy Antifungal (Medline Industries, Inc.)

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CREAM 113 g in 1 TUBE (53329-162-04) Label Information

Complete Remedy Antifungal Information

  • 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.


  • SPL UNCLASSIFIED SECTION

    Medline Remedy is a registered trademark of Medline Industries, Inc.

    Olivamine is a registered trademark of McCord Research, Inc.

    Manufactured for Medline Industries, Inc., Mundelein, IL 60060

    www.medline.com 1-800-MEDLINE


  • 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)

    Label


  • INGREDIENTS AND APPEARANCE
    REMEDY ANTIFUNGAL  WITH OLIVAMINE
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-162
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53329-162-04 113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 01/01/2007
    Labeler - Medline Industries, Inc. (025460908)