SILKA RINGWORM (CLOTRIMAZOLE) CREAM [GENOMMA LAB USA, INC.]

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SILKA RINGWORM (CLOTRIMAZOLE) CREAM [GENOMMA LAB USA, INC.]
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NDC 50066-111-05
Set ID c4e26aa4-248b-48f2-8cdb-630f094259f7
Category HUMAN OTC DRUG LABEL
Packager Genomma Lab USA, Inc.
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 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

    • 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 1 877 99 GENOM (43666)

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Genomma Lab USA Inc., Houston, TX, 77027

  • PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

    SILKA®
    Clotrimazole Cream USP, 1%
    ANTIFUNGAL CREAM

    CURES MOST RINGWORM

    NET WT 0.5 oz (14.2 g)

    Principal Display Panel - 14.2 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SILKA   RINGWORM
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-111
    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)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-111-051 in 1 CARTON12/21/2018
    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 - Genomma Lab USA, Inc. (832323534)
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