NDC 73238-001 Skineez

Vitamin A

NDC Product Code 73238-001

NDC Product Information

Skineez with NDC 73238-001 is a a human over the counter drug product labeled by Cause For Change Llc. The generic name of Skineez is vitamin a. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Cause For Change Llc

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Skineez 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.

  • VITAMIN A .01 1/1

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.

  • SHEA BUTTER (UNII: K49155WL9Y)
  • APRICOT KERNEL OIL (UNII: 54JB35T06A)
  • PLOCAMIUM CARTILAGINEUM (UNII: 37LBZ0E1UE)
  • POTASSIUM OLEATE (UNII: 74WHF607EU)
  • JOJOBA OIL (UNII: 724GKU717M)
  • ROSA CANINA SEED (UNII: 4503R1M9UT)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
  • CAFFEINE (UNII: 3G6A5W338E)
  • UREA (UNII: 8W8T17847W)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • SODIUM ASCORBATE (UNII: S033EH8359)

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: Cause For Change Llc
Labeler Code: 73238
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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 07-22-2019 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: 12-31-2020 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.

Skineez Product Label Images

Skineez 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 Ingredient                                Purpose

Vitamin A 0.01% ---------------------  Skin protectant

Uses

• 24 hour skin hydration • repairs and prevents cracking and scaling• relief for foot arch, heel, ankle and nerve pain• moisturizes, rejuvenates, soothes and nourishes skin

Warnings

For external use onlyWhen using this product if you are allergic to it or any of it's ingredients please remove immmediately.Stop use and ask a doctor if you see or feel any irritation to the skin.

Directions

• After 10 washes, in order to continue receiving the hydrating benefits, the garment will need to be re-infused with SKINEEZ® GARMENT SPRAY® (not included).• Machine wash the garment in cold water with like colors, then while wet turn it inside out and spray the areas of the garment that you wish to re-infuse.• Tumble dry low or lay flat to dry.• Do not Bleach.

Inactive Ingredients

(INCI) of Skintex® Slimming/R6: Butyrospermum Parkii (Shea Butter) Extract, Caffeine, Caprylic/Capric Triglyceride - Gelidium Cartilagineum Extract, Ethylhexylglycerin, Parfum, Phenoxyethanol, Potassium Oleate, Prunus Armeniaca (Apricot) Kernel Oil, Rosa Canina Seed Extract, Seed Oil, Simmondsia Chinensis (Jojoba), Sodium Ascorbate, Sodium Polyacrylate, Tocopherol, Tocopheryl Acetate, Urea

* Please review the disclaimer below.

Previous Code
73237-002
Next Code
73240-902