Label: WALGREENS CLOTRIMAZOLE ANTIFUNGAL- 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 11, 2018

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  • ACTIVE INGREDIENT

    Active ingredient                                                                       Purpose

    Clotrimazole 1%...................................................................... Antifungal

  • PURPOSE

    Uses

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

    Warnings

    For external use only

  • WHEN USING

    When using this product avoid contact with the eyes

  • STOP USE

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks

  • DO NOT USE

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    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
  • STORAGE AND HANDLING

    Other information

    • store between 20° to 25°C (68° to 77°F)
    • Lot No. & Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    2-octyldodecanol, benzyl alcohol, cetearyl alcohol, cetyl esters, monobasic sodium, phosphate dihydrate, polysorbate 60, propylene glycol, purified water, sorbitan stearate

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Walgreen Co.

    200 Wilmot Rd.

    Deerfield, IL 60015

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    17412

  • INGREDIENTS AND APPEARANCE
    WALGREENS CLOTRIMAZOLE ANTIFUNGAL 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7412
    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
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-7412-121 in 1 CARTON11/08/2016
    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 finalpart333C05/18/2015
    Labeler - Walgreen Company (008965063)
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