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  5. Label Information: Footlogix

FDA Label for Footlogix

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTHER
    6. OTC - STOP USE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. INACTIVE INGREDIENT
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Footlogix Product Label

The following document was submitted to the FDA by the labeler of this product Kvg Group Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active IngredientClotrimazole 1%

Otc - Purpose



PurposeAntifungal

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

Other



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

    • 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

Otc - Stop Use



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

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.

Otc - 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

Inactive Ingredient



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

Package Label.Principal Display Panel



Package label

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