FOOTLOGIX MOISTURIZING DIABETIC FORMULA- dimethicone aerosol, foam

footlogix by

Drug Labeling and Warnings

footlogix by is a Otc medication manufactured, distributed, or labeled by KVG Group Inc . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Dimethicone 1%

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

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

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

ASK DOCTOR

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

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 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

SPL UNCLASSIFIED SECTION

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 INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

Product Label

INGREDIENTS AND APPEARANCE

FOOTLOGIX  MOISTURIZING DIABETIC FORMULA
dimethicone aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42479-214
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42479-214-04	119 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/15/2012

Labeler - KVG Group Inc (206932605)