Label: MICONAZOLE NITRATE CREAM USP, 2% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2024

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

View All Sections
  • Active Ingredient

    Miconazole Nitrate 2%

  • Purpose

    Antifungal

  • Uses

    • For the treatment of most athlete's foot, tinea pedis, jock itch, tinea crusis, ringworm, tinea corporis
    • Relieves itching, scaling, burning, 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

    If swallowed, get medical help or contact a Poison Control Center (1800-222-1222) right away.

  • Directions

    • Clean the affected area and dry thoroughly
    • Apply a thin layer 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, and change shoes and socks at least once daily
    • 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 the scalp or nails
  • Other Information

    Store at 15° -30°C (59° -86°F)

  • Inactive Ingredients

    Cetostearyl Alcohol, Chlorocresol, Disodium EDTA, Disodium Hydrogen Phosphate Dihydrate, Light Liquid Paraffin, Macrogol Cetostearyl Ether, Propylene Glycol, Purified Water, Sodium Dihydrogen Phosphate Dihydrate, White Soft Paraffin

  • Questions

    1-888-DYNAREX

  • Label

    CR-1232 Primary Display Panel

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE CREAM USP, 2% 
    miconazole nitrate cream usp, 2% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0340
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0340-128.4 g in 1 TUBE; Type 0: Not a Combination Product07/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00507/30/2018
    Labeler - Cardinal Health (063997360)
    Registrant - Dynarex Corporation (008124539)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!