CLOTRIMAZOLE ANTIFUNGAL (CLOTRIMAZOLE) CREAM [ACTAVIS PHARMA, INC.]

CLOTRIMAZOLE ANTIFUNGAL (CLOTRIMAZOLE) CREAM [ACTAVIS PHARMA, INC.]
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NDC 0472-0350-56
Set ID e03d9368-e1b4-4e37-87e4-3ee241916aed
Category HUMAN OTC DRUG LABEL
Packager Actavis Pharma, Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • 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

  • Warnings

    For external use only

  • Do not use

    on children under 2 years, 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 within 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 the affected area and dry thoroughly
    • apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor
    • 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 last longer, contact a doctor
    • this product is not effective on the scalp or nails
  • Other information

    • Store between 2o-30oC (36o – 86oF).  • Before using any medication, read all label directions.  Keep carton, it contains important information.

  • Inactive ingredients

    benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

  • Questions?

    1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

  • Principal Display Panel

    Actavis
    NDC 0472-0350-56
    Compare to the active ingredient in Lotrimin® AF* 

    Clotrimazole Cream, USP 1%
    Antifungal
    Cures Most Athlete’s Foot
    Relieves: Itching │ Burning │ Cracking │ Scaling 

    Net wt. 1 oz (28 g)

    Clotrimazole Cream
  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE  ANTIFUNGAL
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-0350
    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)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0472-0350-561 in 1 CARTON01/03/2017
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/03/201707/31/2022
    Labeler - Actavis Pharma, Inc. (119723554)