Label: DCH LABS ANTIFUNGAL JOCK- miconazole nitrate 2% powder

  • NDC Code(s): 72839-096-02
  • Packager: Derma Care Research Labs, LLC
  • 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 May 24, 2023

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  • ACTIVE INGREDIENT

    Miconazole Nitrate 2%

  • PURPOSE

    Antifungal

  • INDICATIONS & USAGE

    For the cure of athlete's foot and jock itch. Relieves itching and chafing associated with jock itch.

  • WARNINGS

    For external use only. Do not use on children under 2 years of age unless directed by a doctor or for diaper rash. When using thisproduct avoid contact with the eyes. Stop use and ask a doctor if irritation occurs or if there is no improvement within 2 weeks.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Cleanse the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily or as directed by a doctor or healthcare professional. Supervise children in the use of this product.

    Use daily for 2 weeks.

    If the condition persists, consult a doctor.

    This product is not effective on the scalp or nails.

  • INACTIVE INGREDIENT

    Corn Starch, Fragrance, Potassium Sorbate, Rice Starch, Sodium Benzoate.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    DCH LABS ANTIFUNGAL JOCK 
    miconazole nitrate 2% powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-096
    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
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    STARCH, RICE (UNII: 4DGK8B7I3S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72839-096-0271 g in 1 BOTTLE; Type 0: Not a Combination Product01/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00501/14/2022
    Labeler - Derma Care Research Labs, LLC (116817470)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(72839-096)
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