FDA.reportPublic FDA data

FXP Cracked Heel Formula

Manufacturer
Prime Packaging Inc. | Prime Enterprises Inc
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:17

Label at a glance#

ProductKVG Group, Inc. FXP Cracked Heel Formula
Active ingredientDIMETHICONE
Label structure7 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Footlogix TM

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only

  • Avoid spraying into the eyes

OTC - DO NOT USE SECTION

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

Caution:

WARNINGS AND PRECAUTIONS SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display ImagePrincipal Display Image

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13630-0114-32023-01-30C16284748780-1f386c64a-20b1-0266-e053-dadaa90a7c1aFXP Cracked Heel Formula

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13630-0114-3KVG Group, Inc.FXP Cracked Heel Formula125 mL in 1 CANSPRAY1252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13630-0114KVG GROUP, INC. FXP CRACKED HEEL FORMULA (DIMETHICONE) SPRAY [PRIME PACKAGING INC.]2Legacy NDC, 1 package rows20200121_39a99995-9148-6a39-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13630-011413630-0114-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTANE6LV4FOR43RIACT
PROPANET75W9911L6IACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
CETEARYL ETHYLHEXANOATE9M64UO4C25IACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OACTIB
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
TROLAMINE9O3K93S3TKIACT
UREA8W8T17847WIACT
POLYSORBATE 207T1F30V5YHIACT
STEARIC ACID4ELV7Z65APIACT
EDETATE DISODIUM7FLD91C86KIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
UBIDECARENONEEJ27X76M46IACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9c5c3dc2-4983-7e0b-e053-2995a90a571139a99995-9148-6a39-e054-00144ff8d46c2020-01-17WarningsExact identifier
spl id: 9c5c3dc2-4983-7e0b-e053-2995a90a5711
spl set id: 39a99995-9148-6a39-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.