FOOTLOGIX INTENSIVE CARE DIABETIC FORMULA- clotrimazole aerosol, foam 
KVG Group Inc

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 Footlogix Intensive Diabetic Formula: - with Dermal Infusion Technology for the cure and prevention of fungal infections associated with Athlete’s foot fungus. This Anti-fungal, intensivecare formulation provides effective relief of itching, scaling, cracking, burning, redness and irritation of the skin. Natural skin functions remain unhindered.

Warnings Do not use under children 2 years of age unless directed by a doctor ■ For external use only ■ Avoid spraying into the eyes ■ Do not use on deep wounds, infections or lacerations ■ Supervise children in the use of this product

Stop use and ask a doctor if: irritation occurs or if there is no improvement within 4 weeks there are deep puncture wounds, infections or lacerations

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 the can upright Shake well before each use Use sparingly twice daily for the first two weeks and continue once daily until the problem is corrected  When used as directed, this can contains enough mousse for approximately two months supply If condition persists, consult a doctor

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

Inactive Ingredients Aloe Barbadensis Leaf Juice, Cetearyl Ethylhexanoate, Dimethicone, Disodium EDTA, Glycerin, Methylparaben, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Propylparaben, PVP, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Ubiquinone, Urea, Water.

Package Label
image of package label

FOOTLOGIX INTENSIVE CARE  DIABETIC FORMULA
clotrimazole aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42479-213
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
UREA (UNII: 8W8T17847W)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42479-213-04119 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/15/2012
Labeler - KVG Group Inc (206932605)

Revised: 6/2012
Document Id: 1640faba-7234-4ef6-90c4-c8e55f860ffc
Set id: 6d50530a-7d56-454e-a205-4111cb687840
Version: 2
Effective Time: 20120620
 
KVG Group Inc