FOOTLOGIX INTENSIVE CARE DIABETIC FORMULA- clotrimazole aerosol, foam

footlogix intensive care by

Drug Labeling and Warnings

footlogix intensive care 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
Clotrimazole 1%

PURPOSE

Purpose
Antifungal

INDICATIONS & USAGE

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

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

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

PRINCIPAL DISPLAY PANEL

Package Label

INGREDIENTS AND APPEARANCE

FOOTLOGIX INTENSIVE CARE  DIABETIC FORMULA
clotrimazole aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42479-213
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42479-213-04	119 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	06/15/2012

Labeler - KVG Group Inc (206932605)