KVG GROUP, INC. FXP CRACKED HEEL FORMULA- dimethicone spray 
Prime Packaging 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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FXP Cracked Heel Formula

Active Ingredients

Dimethicone 1%

Purpose

Skin protectant

Footlogix TM

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

Warnings

For external use only

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

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

Principal Display Image

KVG GROUP, INC.  FXP CRACKED HEEL FORMULA
dimethicone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0114
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0114-3125 mL in 1 CAN; Type 0: Not a Combination Product05/21/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/21/2014
Labeler - Prime Packaging Inc. (805987059)
Registrant - Prime Packaging Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc101946028analysis(13630-0114) , manufacture(13630-0114)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging Inc.805987059pack(13630-0114) , label(13630-0114)

Revised: 1/2020
Document Id: 9c5c3dc2-4983-7e0b-e053-2995a90a5711
Set id: 39a99995-9148-6a39-e054-00144ff8d46c
Version: 2
Effective Time: 20200117
 
Prime Packaging Inc.