Label: ANTI-FUNGAL- clotrimazole cream

  • 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 March 11, 2022

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

View All Sections
  • Active Ingredient

    Clotrimazole 1%

  • Purpose

    Anti-Fungal

  • Use

    For the cure of athlete's foot (tinea pedis), jock itch (tinea cruris) and ring worm (tinea corporis).  For relief of itching, scaling, burning and discomfort that accompany these conditions.

  • Warnings

    For exteranl use only.

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

    Do not use on children under 2 years of age unless directed by a doctor.

    Avoid contact with the eyes.

    If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.

    Keep out of reach of children

  • Directions

    Clean the affected area and 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, 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.

  • Inactive Ingredients

    Alkyl acrylate, Capric triglyceride, Cetearyl alcohol, Diazolidinyl urea, Hydroxyethylcellulose, Methylparaben, Propylparaben, Retinyl palmitate, Silica, Tetrasodium EDTA, Tocopheryl Acetate, Triethanolmine, Water

  • Package Label

    MP00023 MPM Anti-Fungal Cream 4 oz

  • INGREDIENTS AND APPEARANCE
    ANTI-FUNGAL 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66977-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TETRASODIUM EDETATE DIHYDRATE (UNII: 3JGX4KKZ4A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66977-023-04113 g in 1 TUBE; Type 0: Not a Combination Product10/14/2002
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/14/2002
    Labeler - MPM Medical, LLC (081241522)
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!