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footlogix

Dosage form: aerosol, spray
Ingredients: CLOTRIMAZOLE 1mL in 100mL
Labeler: KVG Group Inc
NDC Code: 42479-212

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 Facts

Active Ingredient
Clotrimazole 1%

Purpose
Antifungal

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

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

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

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

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

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

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

Package label

FOOTLOGIX  
clotrimazole aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42479-212
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTANE 
PANTHENOL 
PROPANE 
PROPYLENE GLYCOL 
AVOCADO 
Packaging
#Item CodePackage Description
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/FEIOperations
Assured Packaging Inc248916165manufacture

Revised: 08/2010
 
KVG Group Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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