Label: ALOE VESTA- miconazole nitrate ointment

  • NDC Code(s): 53329-774-14, 53329-774-64
  • Packager: Medline Industries, LP
  • 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 August 8, 2023

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  • Active ingredient

    Miconazol nitrate 2% w/w

  • 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 the treatment of most superficial skin infections caused by yeast (Candida albicans)
    • follow a physician's instructions when treating Candida albicans
  • 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

    Stop use and ask doctor if

    there is no improvement within 2 weeks for jock itch, or 4 weeks for athlete's foot or ringworm

    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 doctor
    • this product is not effective on the scalp or nails
  • Inactive ingredients

    aloe barbadensis leaf extract, bis-diglyceryl polyacyladipate-2, mineral oil, white petrolatum

  • Manufacturing Information

    Manufactured for: Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA of foreign and domestic materials

    www.medline.com

    1-800-MEDLINE

    REF: 325105

    V1 RE21GSG

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    ALOE VESTA 
    miconazole nitrate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-774
    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)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-774-1456 g in 1 TUBE; Type 0: Not a Combination Product09/30/2020
    2NDC:53329-774-64141 g in 1 TUBE; Type 0: Not a Combination Product09/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00509/30/2020
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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