Label: CLOTRIMAZOLE cream

  • NDC Code(s): 45802-434-01, 45802-434-11
  • Packager: Padagis Israel Pharmaceuticals Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 9, 2024

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  • 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 1 OZ (30 g)

    Padagis™

    Clotrimazole Cream Carton Image
  • 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 CARTON06/03/201101/31/2026
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:45802-434-111 in 1 CARTON06/09/201102/28/2026
    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 DrugM00506/03/201102/28/2026
    Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
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