FOOTLOGIX MOISTURIZING DIABETIC FORMULA- dimethicone 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.

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Drug Facts

Active Ingredient

Dimethicone 1%

Purpose

Skin Protectant

Uses: Footlogix Moisturizing Diabetic Formula- with Dermal Infusion Technology is an effective daily maintenance formula that hydrates and relieves the extremely dry, cracked skin of the feet. This unique fragrance-free, lightweight mousse formula also softens, protects the skni and prevents damage due to dryness by replenishing the skin's moisture barrier.

Warnings ■ Do not use on 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, Butylene Glycol, Cetearyl Ethylhexanoate, Disodium EDTA, Glycerin, Isostearic Acid, Methylparaben, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Propylparaben, PVP, SD Alcohol 40-B, Sorbitol, Spirulina Platensis Extract, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Ubiquinone, Urea, Water.

Product Label
image of package label

FOOTLOGIX  MOISTURIZING DIABETIC FORMULA
dimethicone aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42479-214
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POVIDONE (UNII: FZ989GH94E)  
SORBITOL (UNII: 506T60A25R)  
SPIRULINA PLATENSIS (UNII: 9L3TIH1UUE)  
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:42479-214-04119 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/15/2012
Labeler - KVG Group Inc (206932605)

Revised: 6/2012
Document Id: 20ce9225-fb52-4a93-9b9a-3bfa36b17806
Set id: 4fa7bd2b-04c4-4d86-9e5f-e70e6020e5b8
Version: 1
Effective Time: 20120628
 
KVG Group Inc