FOOTLOGIX- clotrimazole aerosol, spray

footlogix by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient
Clotrimazole 1%

PURPOSE

Purpose
Antifungal

INDICATIONS & USAGE

Use 

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

WARNINGS

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

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
  

STOP USE

Stop use and ask a doctor if

• irritation occurs or if there is no improvement within 4 weeks

PREGNANCY OR BREAST FEEDING

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

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 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

SPL UNCLASSIFIED SECTION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Package label

INGREDIENTS AND APPEARANCE

FOOTLOGIX  
clotrimazole aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42479-212
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
BUTANE (UNII: 6LV4FOR43R)
PANTHENOL (UNII: WV9CM0O67Z)
PROPANE (UNII: T75W9911L6)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AVOCADO (UNII: SDS87L369F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42479-212-17	50 mL in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333	09/01/2010

Labeler - KVG Group Inc (206932605)

Establishment
Name	Address	ID/FEI	Business Operations
Assured Packaging Inc		248916165	manufacture