RITE AID ANTIFUNGAL RINGWORM (CLOTRIMAZOLE) CREAM [RITE AID CORPORATION]

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RITE AID ANTIFUNGAL RINGWORM (CLOTRIMAZOLE) CREAM [RITE AID CORPORATION]
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NDC 11822-1110-1
Set ID 1ad7cd82-d01b-403e-a2c1-2302db2a78df
Category HUMAN OTC DRUG LABEL
Packager Rite Aid Corporation
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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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 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

    • To open: unscrew cap, use the pointed end of cap to puncture seal.
    • store between 20°- 25°C (68° - 77°F)
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

    benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    RITE AID, 30 HUNTER LANE,
    CAMP HILL, PA 17011

  • PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

    RITE
    AID®
    PHARMACY

    Ringworm Cream

    Clotrimazole Cream USP, 1%

    ANTIFUNGAL

    NET WT 0.5 OZ (14.2 g)

    Principal Display Panel - 14.2 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    RITE AID   ANTIFUNGAL RINGWORM
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1110
    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:11822-1110-11 in 1 CARTON06/01/1995
    114.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C06/01/1995
    Labeler - Rite Aid Corporation (014578892)
    Registrant - Taro Pharmaceuticals U.S.A., Inc (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(11822-1110)
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