Label: FOOTLOGIX- clotrimazole aerosol, spray

  • 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 August 19, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient
    Clotrimazole 1%
  • PURPOSE

    Purpose
    Antifungal
  • INDICATIONS & USAGE

    Use 
    • For the cure of most athlete’s foot (tinea pedis)
    • ringworm (tinea corporis)
  • WARNINGS

    Warnings 
    • For external use only 
    • Do not use on children under 2 years of age unless directed by a doctor 
    • For external use only  
    • Avoid spraying into the eyes
  • SPL UNCLASSIFIED SECTION

    Caution:
    • Contents are under pressure
    • Protect from direct sunlight and do not store at temperatures above 120F/50C
    • After use, do not puncture or incinerate container
    • Spray only in a well ventilated area
    •  Do not spray in presence of open flame or spark or while smoking
  • STOP USE

    Stop use and ask a doctor if
    • irritation occurs or if there is no improvement within 4 weeks
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately.
  • DOSAGE & ADMINISTRATION

    Directions

    • Clean the affected area and dry thoroughly 
    • Hold can upright
    • Shake can well before each use  
    • Spray a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor. 
    • Supervise children in the use of this product
    • For athlete’s foot and ringworm, use daily for 4 weeks
    • If condition persists longer, consult a doctor
  • SPL UNCLASSIFIED SECTION

    Other information

    • For athlete’s foot Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
    • This product is not effective on the scalp
  • INACTIVE INGREDIENT

    Inactive Ingredients  Butane, Panthenol, Propylene Glycol, (and) Persea Gratissima (Avocado) Fruit Extract, SD Alcohol 40-B, Undecylenamide DEA
  • PRINCIPAL DISPLAY PANEL

    Package label
    image of package label

  • INGREDIENTS AND APPEARANCE
    FOOTLOGIX  
    clotrimazole aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42479-212
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTANE (UNII: 6LV4FOR43R)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PROPANE (UNII: T75W9911L6)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AVOCADO (UNII: SDS87L369F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42479-212-1750 mL in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33309/01/2010
    Labeler - KVG Group Inc (206932605)
    Establishment
    NameAddressID/FEIBusiness Operations
    Assured Packaging Inc248916165manufacture
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