REMEDY WITH PHYTOPLEX (MICONAZOLE NITRATE) OINTMENT [MEDLINE INDUSTRIES INC.]

REMEDY WITH PHYTOPLEX (MICONAZOLE NITRATE) OINTMENT [MEDLINE INDUSTRIES INC.]
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NDC 53329-171-10
Set ID 3a5cda93-2606-65d4-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Medline Industries, LP
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • Active ingredient

    Miconazole Nitrate 2.0%

  • 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
    • on scalp or nails

    When using this product

    • avoid contact with the eyes

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks for athlete's foot and ringworm
    • there is no improvement within 2 weeks for jock itch

    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 ointment 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

    7-dehydrocholestrol, aphanizomenon flos-aquae (algae) extract, camellia sinensis (green tea) extract, caprylic/capric triglycerides, carboxymethyl cellulose, carthamus tinctorius (safflower) seed oil, dimethicone, eugenia caryophyllus (clove) flower extract, glycerin, hydrolyzed soy protein, olea europaea fruit (olive) oil, petrolatum, phospholipids, tocopherol acetate, water, yeast ferment extract, zea mays (corn) oil

  • Package/Label Principal Display Panel

    NDC 53329-171-10

    MEDLINE

    REMEDY®

    PHYTOPLEX®

    Botanical Nutrition for Sensitive Skin

    Treatment

    Antifungal Ointment

    Miconazole Nitrate 2%

    Helps treat and relieve itching

    & burning associated with a fungal infection

    CHG Compatible

    Paraben Free

    Hypoallergenic

    Net Wt 2.5 oz (71 g)

    Tube label

  • INGREDIENTS AND APPEARANCE
    REMEDY WITH PHYTOPLEX 
    miconazole nitrate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-171
    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
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CLOVE (UNII: K48IKT5321)  
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CORN OIL (UNII: 8470G57WFM)  
    APHANIZOMENON FLOS-AQUAE (UNII: 49VG1X560X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    YEAST (UNII: 3NY3SM6B8U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-171-1071 g in 1 TUBE; Type 0: Not a Combination Product04/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/11/2016
    Labeler - Medline Industries, LP (025460908)

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