CLOTRIMAZOLE CREAM [KINRAY INC.]

CLOTRIMAZOLE CREAM [KINRAY INC.]
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NDC 63777-231-01
Set ID 93900b18-3327-41a5-b666-e80727407d42
Category HUMAN OTC DRUG LABEL
Packager Kinray Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • Purpose


    • For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
    • For the treatment of superficial skin infections caused by Yeast (Candida Albicans).
    • Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch.
  • Active Ingredient

    Active Ingredient                         Purpose

    Clotrimazole 1.0%                      Antifungal

  • Warnings

    Do not use:

    • Do not use on children under 2 years of age unless directed by a doctor.
    • Avoid contact with eyes.
    • For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
    • For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.
    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Indications & Usage



    • Supervise children in the use of this product.
    • If conditions persist longer, consult a doctor.
    • This product is not effective on scalp or nails.
  • Other information.

    Protect from freezing. Avoid excessive heat.

  • Dosage & Administration

    • Clean the affected area and dry thoroughly. Apply a layer of cream over affected area twice daily (morning and night) or as directed by a doctor.
    • Foe athlete's foot and ringworm, use daily for 4 weeks.
    • For jock itch, use daily for 2 weeks.
    • For athlete's foot, pay special attention to spaces between toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
  • Inactive Ingredients

    Inactive Ingredients: Cetomacrogol 1000, cetostearyl alcohol, liquid paraffin, methylparaben, propylene glycol, propylparaben, purified water, white soft paraffin.

  • Keep Out of Reach of Children


    • KEEP OUT OF REACH OF CHILDREN
    • If swallowed get medical help or contact a Poison Control Center.
  • Principal Display Panel

    Kinray Antifungal

    KR_Antifungal.jpg

    Kinray antifungal

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63777-231
    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
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63777-231-0128.4 g in 1 TUBE; Type 0: Not a Combination Product01/11/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/11/2012
    Labeler - Kinray Inc. (012574513)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blossom Pharmaceuticals677381470manufacture(63777-231)

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