Label: ALOE VESTA CLEAR ANTIFUNGAL 56G- miconazole nitrate ointment

  • 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 June 18, 2016

If you are a consumer or patient please visit this version.

  • Drug Facts
  • 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 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.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact 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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  • Active ingredient

    Miconazole Nitrate 2%

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  • Purpose

    Antifungal

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  • Inactive ingredients

    Aloe Barbadensis Leaf Extract, Bis-Diglyceryl Polyacladipate-2, Mineral Oil, Petrolatum

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  • STORAGE AND HANDLING

    Store at 15°C -30°C (59°F - 86°F)

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  • SPL UNCLASSIFIED SECTION

    CLEAR ANTIFUNGAL OINTMENT

    • CHG Compatible
    • Cures Most:

        -Athlete's Foot
        -Ringworm
        -Jock Itch
        -Superficial Yeast Infections

    • Fragrance & Dye Free

    with 2 %  Miconazole Nitrate and a Natural Botanical

    Manufactured for:
    ConvaTec

    ConvaTec Inc.
    Greensboro, NC 27409
    1-800-422-8811
    www.convatec.com

    Made in USA

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  • Packaging
  • INGREDIENTS AND APPEARANCE
    ALOE VESTA CLEAR ANTIFUNGAL 56G 
    miconazole nitrate ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11099-0003
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 1.12 g  in 56 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11099-0003-2 56 g in 1 TUBE; Type 0: Not a Combination Product 06/09/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 06/09/2016
    Labeler - Guest Packaging LLC. (001773076)
    Establishment
    Name Address ID/FEI Business Operations
    Guest Packaging LLC. 001773076 manufacture(11099-0003)
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