Label: EVERCARE ANTIFUNGAL TREATMENT SUPER ABSORBENT POWDER- miconazole nitrate 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 November 9, 2022

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  • Drug Facts

  • Active Ingredient

    Miconazole Nitrate 2%

    Purpose

    Antifungal

  • Use

    for the cure of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tea corporis) for effective relief of itching, cracking, burning, scaling and discomfort

  • Warnings

    For external use only.

    Flammable, Do not use while smoking or near heat or flame. 

    Do not use

    on children under 2 years of age unless directed by a doctor

    When using this product

    • avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.

    Stop use and ask a doctor

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

    Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    clean the affected area& dry thoroughly apply a thin layerof 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 attenting to spaces between the toes;wear wellfitting, 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 between 59-86 °F 

    • lightly shake bottle to loosen settled powder
  • Inactive ingredients

    corn starch, sodium bicarbonate, kaolin, zinc oxide, calamine

  • Package Labeling:

    Label01

  • INGREDIENTS AND APPEARANCE
    EVERCARE ANTIFUNGAL TREATMENT SUPER ABSORBENT POWDER 
    miconazole nitrate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83099-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    KAOLIN (UNII: 24H4NWX5CO)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83099-000-0085 g in 1 POUCH; Type 0: Not a Combination Product11/28/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C11/28/2022
    Labeler - PANEFFORT, LLC (018250858)
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