Label: CLOTRIMAZOLE cream

  • NDC Code(s): 45802-434-01, 45802-434-11
  • Packager: Perrigo New York Inc
  • 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 3, 2019

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

  • Active ingredient

    Clotrimazole 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.

    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
  • Other information

    store at 20°-25°C (68°-77°F)
  • Inactive ingredients

    benzyl alcohol, cetostearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Cures Most Athlete’s Foot

    Relieves Itching & Burning

    Greaseless, Non-Staining

    Compare to Lotrimin® AF active ingredient

    Clotrimazole Cream USP, 1%

    Antifungal

    NET WT 0.5 OZ (15 g)

    Clotrimazole Image 1
    Clotrimazole Image 2
  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-434
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45802-434-011 in 1 CARTON06/03/2011
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:45802-434-111 in 1 CARTON06/09/2011
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/03/2011
    Labeler - Perrigo New York Inc (078846912)