NDC 13630-0114 Kvg Group, Inc. Fxp Cracked Heel Formula

Dimethicone

NDC Product Code 13630-0114

NDC CODE: 13630-0114

Proprietary Name: Kvg Group, Inc. Fxp Cracked Heel Formula What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Dimethicone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum) are used mostly to protect the skin against irritation (e.g., from wetness). Dry skin is caused by a loss of water in the upper layer of the skin. Emollients/moisturizers work by forming an oily layer on the top of the skin that traps water in the skin. Petrolatum, lanolin, mineral oil and dimethicone are common emollients. Humectants, including glycerin, lecithin, and propylene glycol, draw water into the outer layer of skin. Many products also have ingredients that soften the horny substance (keratin) that holds the top layer of skin cells together (e.g., urea, alpha hydroxy acids such as lactic/citric/glycolic acid, and allantoin). This helps the dead skin cells fall off, helps the skin keep in more water, and leaves the skin feeling smoother and softer.

NDC Code Structure

  • 13630 - Prime Packaging Inc.

NDC 13630-0114-3

Package Description: 125 mL in 1 CAN

NDC Product Information

Kvg Group, Inc. Fxp Cracked Heel Formula with NDC 13630-0114 is a a human over the counter drug product labeled by Prime Packaging Inc.. The generic name of Kvg Group, Inc. Fxp Cracked Heel Formula is dimethicone. The product's dosage form is spray and is administered via topical form.

Labeler Name: Prime Packaging Inc.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Kvg Group, Inc. Fxp Cracked Heel Formula Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DIMETHICONE 10.2 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

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

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Prime Packaging Inc.
Labeler Code: 13630
FDA Application Number: part347 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-21-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Kvg Group, Inc. Fxp Cracked Heel Formula Product Label Images

Kvg Group, Inc. Fxp Cracked Heel Formula Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Dimethicone 1%

Purpose

Skin protectant

Footlogix Tm

  • Cracked Heel Formula: Moisturizes and protects extremely callused, cracked skin
  • Natural skin functions remain unhinderedIs absorbed immediately without any greasy residueClothing can be worn immediately after applicationFree of perfumesDermatologist tested

Warnings

  • For external use onlyAvoid spraying into the eyes

Otc - Do Not Use

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

Caution:

  • Contents are under pressureProtect from direct sunlight and do not store at temperatures above 120ºF / 50ºCAfter use, do not puncture or incinerate containerSpray only in a well ventilated areaDo not spray in the presence of an open flame, spark or while smoking

Otc - Stop Use

  • 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

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

Otc - Keep Out Of Reach Of Children

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 thoroughlyHold can uprightShake can well before each useUse sparingly twice daily for the first two weeks and continue once daily until the problem is correctedWhen used as directed, this can contains enough mousse for approximately two months supplySupervise 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.

* Please review the disclaimer below.