Label: ALOE VESTA ANTIFUNGAL - miconazole nitrate ointment

  • NDC Code(s): 43553-3251-2, 43553-3251-5
  • Packager: ConvaTec, 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 April 8, 2011

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  • Active Ingredient

    Miconazole Nitrate 2%

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  • Purpose

    Antifungal

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  • Uses

    • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
    • Relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomfort that accompany these conditions.
    • For the treatment of most superficial skin infections caused by yeast (Candida albicans).
    • Follow a physician's instructions when treating Candida.
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  • Warnings

    For external use only.

    Do not use on

    children under 2 years of age unless directed by a physician.

    When using this product,

    avoid contact with eyes.

    If irritation occurs

    or if there is no improvement within 2 weeks for jock itch, or 4 weeks for athlete's foot or ringworm, discontinue use and consult a physician.

    Keep out of reach of children.

    If swallowed, get medical help or consult a Poison Control Center right away.

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  • Directions

    Clean the affected area and dry thoroughly.

    • Apply a thin layer of ointment over affected area twice daily (morning and night) or as directed by a physician.
    • Supervise children in use of this product. 
    For athlete's foot:  Pay close 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 physician.
    • This product is not effective on the scalp or nails.
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  • Other Information

    Store at 15oC - 30oC (59oF - 86oF).

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  • Inactive Ingredients

    Aloe Extract, Light Mineral Oil, Softisan 649, White Petrolatum.

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  • PRINCIPAL DISPLAY PANEL

    Aloe Vesta Antifungal Ointment Label

    NDC 43553-3251-2

    ConvaTec

    ALOE VESTATM

    Antifungal Ointment

    TREAT

    Miconazole Nitrate 2%

    CURES MOST:

    Athlete's Foot

    Ringworm

    Jock Itch

    Superficial Yeast Infections

    NET WT. 2oz.(56g)

    CSX0647A Case Order No. 325102

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  • INGREDIENTS AND APPEARANCE
    ALOE VESTA ANTIFUNGAL 
    miconazole nitrate ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43553-3251
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    Color white (white to off-white) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43553-3251-2 56 g in 1 TUBE
    2 NDC:43553-3251-5 141 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 10/03/1997
    Labeler - ConvaTec, Inc. (947989757)
    Registrant - ConvaTec, Inc. (947989757)
    Establishment
    Name Address ID/FEI Business Operations
    Guest Packaging LLC 001773076 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Medicia 091396697 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    ConvaTec, Inc. 947989757 analysis
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