Label: ANTIFUNGAL CREAM- antifungal cream

  • NDC Code(s): 68001-481-45, 68001-481-47, 68001-481-48
  • Packager: BluePoint Laboratories
  • 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 December 1, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Active Ingredient Purpose







    Miconazole Nitrate 2% Antifungal

  • Purpose

    • For the treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
    • For the treatment of superficial skin infections caused by Yeast (Candida Albicans)
    • Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort 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.
    • avoid contact with eyes
    • for athlete's foot and ringworm- if irritation occurs, or if there is no improvement within 4 weeks, discotinue use and consult a doctor
    • for jock itch- if irritation occurs, or if there is no improvement within 2 weeks, discontinue use and consult a doctor.
    • for diaper rash

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Indications and Usage

    • Clean the affected area and dry thoroughly. Apply a thin layer of cream 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 toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.

  • Dosage and Administration

    • 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 scalp or nails.
  • Keep Out Of Reach Of Children

    KEEP OUT Of REACH Of CHILDREN

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

  • INACTIVE INGREDIENTS

    Inactive Ingredients: Cetomacrogol 1000, Cetostearyl alcohol, Chlorocresol,Liquid paraffin, Propylene glycol, Purified water, White soft paraben

  • QUESTIONS

    Contact 1-800-707-4621

  • STORAGE AND HANDLING

    • Store at 15 0 to 30℃ ( 59 0 to 86 0 F)
    • Preserve in thight containers
  • 2% Miconazole Nitrate Cream, USP Carton

    Fig 1

  • 2 % Miconazole Nitrate Cream, USP Tube Label

    Fig 2

  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL CREAM 
    antifungal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-481
    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
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68001-481-451 in 1 CARTON12/01/2020
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68001-481-471 in 1 CARTON12/01/2020
    242 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:68001-481-481 in 1 CARTON12/01/2020
    315 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/01/2020
    Labeler - BluePoint Laboratories (985523874)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gopaldas Visram & Co., Ltd858030888manufacture(68001-481)