Label: CLOTRIMAZOLE ANTIFUNGAL- 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 May 15, 2023

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

  • Drug Facts

  • Active ingredient

    Clotrimazole USP 1%

  • Purpose

    Antifungal

  • Uses

    • cures most athlete's foot, jock itch and ringworm
    • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
  • Warnings

    For external use only

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

    When using this product avoid contact with the eyes

    Stop use and ask a doctor if • irritation occurs • 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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    • wash the affected area and dry thoroughly
    • apply a thin layer over affected area twice daily (morning and night)
    • supervise children in the use of this product
    • for athlete's foot pay special attention to the 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

    Cetostearyl alcohol, Cetomacrogol 1000, Micro wax, Light liquid paraffin, Paraffin wax, Chlorocresol, Propylene Glycol, Purified water

  • Other information

    • Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal

    • store at temperature not exceeding 30°C (86°F). Do not freeze. • See crimp of tube or carton for Lot Number and Expiration Date

  • Questions or comments?

    1 844 500-2729‬ between 9 am and 4 pm EST, Monday to Friday.

  • SPL UNCLASSIFIED SECTION

    Cures Most Athlete's Foot

    Relieves Itching & Burning, Relieves Cracking and Scaling, Grease less, Non-Staining

    Compared to the active ingredient in Lotrimin AF

    Distributed by.

    ARU PHARMA INC.

    MOUNT VERNON, NY 10552

    www.qpackrx.com

  • Packaging

    Clotrmzle1

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE ANTIFUNGAL 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70403-925
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 (UNII: I835H2IHHX)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (white to off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70403-925-301 in 1 CARTON01/01/201803/31/2025
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/201803/31/2025
    Labeler - Aru Pharma Inc. (079736192)