Label: LOTRIMIN- 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 December 1, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    • cures most ringworm
    • relieves itching, redness, irritation and discomfort which accompany this condition
  • Warnings

    For external use only

    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

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

    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
    • use daily for 4 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?

    1-866-360-3266

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

    LotriminRWLOTRIMIN ® AF

    ANTIFUNGAL

    clotrimazole cream

    NET WT 12g (0.42 OZ)

  • INGREDIENTS AND APPEARANCE
    LOTRIMIN 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-6549
    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
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    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:11523-6549-11 in 1 CARTON01/02/2009
    112 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/02/2009
    Labeler - Bayer HealthCare LLC. (112117283)