Label: GERIGENTLE MICONAZOLE NITRATE- antifungal powder

  • NDC Code(s): 69771-165-03
  • Packager: GERI-GENTLE CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 24, 2023

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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
    GERIGENTLE MICONAZOLE NITRATE 
    antifungal powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69771-165
    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:69771-165-0385 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 DrugM00508/19/2022
    Labeler - GERI-GENTLE CORPORATION (080367686)
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