Label: PRO-EX ANTI FUNGAL- clotrimazole cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/12

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  • ACTIVE INGREDIENT

    Active Ingredients
    Clotrimazole 1%

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  • PURPOSE

    Purpose
    Antifungal Close
  • INDICATIONS & USAGE

    Uses
    • cures most jock itch
    • relieves itching, burning, cracking,scaling and discomfort associated with jock itch
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  • WARNINGS

    Warnings
    For external use only Close
  • DO NOT USE

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

    When using this product avoid contact with eyes Close
  • STOP USE

    Stop use and ask a doctor if
    •  irritation occurs
    •  there is no improvement within 2 weeks
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Close
  • DOSAGE & ADMINISTRATION

    Directions
    • wash affected area and dry thoroughly
    • apply a thin layer over the affected area twice daily (morning and night)
    • supervise children in the use of this product
    • use daily for 2 weeks
    • if condition persists longer, ask a doctor
    • this product is not effective on the scalp and nails
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  • OTHER SAFETY INFORMATION

    Other Information
    • Store between 15 and 30 C (59 and 86 F)
    • Do not use if seal on tube is punctured or missing
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  • INACTIVE INGREDIENT

    Inactive Ingredients
    Aloe barbadensis (aloe) leaf juice, carbomer, cetyl alcohol, DMDM Hydantoin, glyceryl stearate, methylparaben, mineral oil, polysorbate 20, propylparaben, stearic acid, triethanolamine, trisodium edta, water Close
  • PRINCIPAL DISPLAY PANEL

    Pro EX artPACKAGE  LABEL

    Antifungal Cream
    Clotrimazole cream
    Cures Most Jock Itch
    Relieves Itching, Burning and Chafing
    Compare to Lotrimin AF


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  • INGREDIENTS AND APPEARANCE
    PRO-EX  ANTI FUNGAL
    clotrimazole cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67234-014
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Clotrimazole (Clotrimazole) Clotrimazole 0.01 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    CARBOMER HOMOPOLYMER TYPE C  
    CETYL ALCOHOL  
    DMDM HYDANTOIN  
    GLYCERYL MONOSTEARATE  
    METHYLPARABEN  
    MINERAL OIL  
    POLYSORBATE 20  
    PROPYLPARABEN  
    STEARIC ACID  
    TROLAMINE  
    EDETATE TRISODIUM  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67234-014-01 42 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 01/22/2008
    Labeler - Natureplex, LLC (062808196)
    Establishment
    Name Address ID/FEI Business Operations
    Natureplex, LLC 062808196 manufacture
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