Label: LOTRIMIN- clotrimazole cream

  • NDC Code(s): 11523-0963-1, 11523-0963-2, 11523-0963-5, 11523-0963-7
  • Packager: Bayer HealthCare LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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.

  • Directions

    • wash 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 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, ask a doctor
    • this product is not effective on the scalp or nails
  • Other information

    store between 20° to 25°C (68° to 77°F)

  • Inactive ingredients

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

  • Questions?

    866-360-3226

  • SPL UNCLASSIFIED SECTION

    Distributed by Bayer HealthCare LLC, Whippany, NJ, USA, 07981

  • PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

    Lotrimin AF 0963

    LOTRIMIN ®AF

    clotrimazole cream

    ANTIFUNGAL

    NET WT 12g (0.42 OZ)

  • INGREDIENTS AND APPEARANCE
    LOTRIMIN 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0963
    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
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (White to Off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0963-11 in 1 CARTON02/01/2002
    130 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11523-0963-21 in 1 CARTON02/01/2002
    215 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:11523-0963-51 in 1 CARTON02/01/2002
    312 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:11523-0963-71 in 1 CARTON02/01/2002
    424 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00502/01/2002
    Labeler - Bayer HealthCare LLC (112117283)
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