KVG GROUP, INC. FXP CRACKED HEEL FORMULA- dimethicone spray

KVG Group, Inc. by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Dimethicone 1%

Purpose

Skin protectant

Footlogix TM

Cracked Heel Formula: Moisturizes and protects extremely callused, cracked skin

• Natural skin functions remain unhindered
• Is absorbed immediately without any greasy residue
• Clothing can be worn immediately after application
• Free of perfumes
• Dermatologist tested

Warnings

For external use only

• Avoid spraying into the eyes

Do not use on deep wounds, animal bites or serious burns

Caution:

Contents are under pressure

• Protect from direct sunlight and do not store at temperatures above 120ºF / 50ºC
• After use, do not puncture or incinerate container
• Spray only in a well ventilated area
• Do not spray in the presence of an open flame, spark or while smoking

Stop use and ask a doctor if: Condition worsens

• symptoms last more than 7 days or clear up and re-occur within a few days

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

Keep out of reach of children. In case of accidental ingestion, contact a doctor or Poison Control Center immediately.

Directions:

Clean the affected area and dry thoroughly

• Hold can upright
• Shake can 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
• Supervise children in the use of this product

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Butane, Cetearyl Ethylhexanoate, Disodium EDTA, Glycerin, Stearic Acid, Methylparaben, Oenothera Biennis Oil, Phenoxyethanol, Polysorbate 20, Propane, Propylene Glycol, Propylparaben, PVP, Tocopheryl Acetate, Triethanolamine, Ubiquinone, Urea, Water.

FXP Cracked Heel Formula

INGREDIENTS AND APPEARANCE

KVG GROUP, INC.  FXP CRACKED HEEL FORMULA
dimethicone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTANE (UNII: 6LV4FOR43R)
PROPANE (UNII: T75W9911L6)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TROLAMINE (UNII: 9O3K93S3TK)
UREA (UNII: 8W8T17847W)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
UBIDECARENONE (UNII: EJ27X76M46)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0114-3	125 mL in 1 CAN; Type 0: Not a Combination Product	05/21/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/21/2014

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc		101946028	analysis(13630-0114) , manufacture(13630-0114)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging Inc.		805987059	pack(13630-0114) , label(13630-0114)