Label: ALOE VESTA CLEAR ANTIFUNGAL- miconazole nitrate ointment

  • NDC Code(s): 43553-0003-2, 43553-0003-5
  • 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 November 19, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Miconazole Nitrate 2 percent

  • Purpose

    Antifungal

  • 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.
  • 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 contact a Poison Control Center right away.

  • 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.
  • Inactive Ingredients

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

  • Package label

    NDC 43553-0003-2

    REF 325102

    ALOE VESTA ​TM

    TREAT

    CLEAR ANTIFUNGAL

    OINTMENT

    • CHG Compatible
    • Cures Most:

      -Athlete's Foot

      -Ringworm

      -Jock Itch

      -Superficial Yeast Infections
    • Fragrance & Dye Free

    with 2 percent Miconazole Nitrate and a Natural Botanical

    Net Wt. 2 oz. (56g)

    Manufactured for:

    ConvaTec

    ConvaTec Inc.

    Skillman, NJ 08558

    1-800-422-8811

    www.convatec.com

    ©2015 ConvaTec Inc.

    ®/ ​TM ​indicates a trademark of ConvaTec Inc.

    Store at 15°C - 30°C (59°F - 86°F)

    Made in USA

    CSX0647D

    4355300003

  • INGREDIENTS AND APPEARANCE
    ALOE VESTA CLEAR ANTIFUNGAL 
    miconazole nitrate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43553-0003
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43553-0003-256 g in 1 TUBE; Type 0: Not a Combination Product12/23/2013
    2NDC:43553-0003-5141 g in 1 TUBE; Type 0: Not a Combination Product12/23/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/20/2013
    Labeler - Convatec Inc. (080128290)