KVG Group, Inc. FXP Cracked Heel Formula: Package Insert and Label Information

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.

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 10.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BUTANE
PROPANE
EVENING PRIMROSE OIL
CETEARYL ETHYLHEXANOATE
ALOE VERA LEAF
WATER
GLYCERIN
PHENOXYETHANOL
POVIDONE, UNSPECIFIED
TROLAMINE
UREA
POLYSORBATE 20
STEARIC ACID
EDETATE DISODIUM
METHYLPARABEN
PROPYLPARABEN
.ALPHA.-TOCOPHEROL ACETATE
UBIDECARENONE
PROPYLENE GLYCOL
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13630-0114-3 125 mL in 1 CAN None
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 Operations
Prime Enterprises Inc 101946028 analysis (13630-0114), manufacture (13630-0114)
Establishment
Name Address ID/FEI Operations
Prime Packaging Inc. 805987059 pack (13630-0114), label (13630-0114)

Revised: 01/2020 Prime Packaging Inc.

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