Label: ASTONEA MICONAZOLE NITRATE- antifungal powder

  • 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 19, 2022

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  • Active Ingredients

    Miconazole nitrate 2%

  • Purpose

    Antifungal

  • Uses

    fFor the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) ■Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch or itching, burning feet

  • Warnings

    For external use only.

    Do not use

    : ■On children under 2 years of age unless directed by a doctor ■For diaper rash

    When using this product

    avoid contact with the eyes

    Stop use and ask a doctor if

    ■Irritation occurs

    ■There is no improvement within 2 weeks when used for the treatment of jock itch ■There is no improvement within 4 weeks when used 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 & dry thoroughly
    • apply a thin layer of the product 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, & change shoes & socks at least once daily
    • for athlete's foot & 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

    • Store at room temperature
  • Inactive ingredients

    Colloidal Anhyhdrous Silica, Talcum Powder

  • Questions?

    Call 1-866-964-0939

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  • INGREDIENTS AND APPEARANCE
    ASTONEA MICONAZOLE NITRATE 
    antifungal powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-165
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77338-165-0385 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/19/2022
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
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