FOOTLOGIX (CLOTRIMAZOLE) AEROSOL, SPRAY [KVG GROUP INC ]

FOOTLOGIX (CLOTRIMAZOLE) AEROSOL, SPRAY [KVG GROUP INC ]
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NDC 42479-212-17
Set ID d1e56f5f-3665-420c-9753-6c1c38ba112f
Category HUMAN OTC DRUG LABEL
Packager KVG Group Inc
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333
  • 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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