Footlogix
FDA Label NDC 42479-212

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kvg Group Inc for the product Footlogix (NDC 42479-212). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, other, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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Package label

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