NDC 46783-004 After Care
Dimethicone Cream Topical

Product Information

Product Code46783-004
Proprietary Name 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.
After Care
Non-Proprietary Name 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.
Dimethicone
Product Type 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.
Human Otc Drug
Dosage FormCream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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.
Merz North America
Labeler Code46783
FDA Application Number 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.
part347
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
04-01-2019
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Packages

NDC 46783-004-04

Package Description: 4 mL in 1 TUBE

NDC 46783-004-15

Package Description: 1 BOTTLE in 1 CARTON > 15 mL in 1 BOTTLE

NDC 46783-004-20

Package Description: 1 BOTTLE in 1 CARTON > 200 mL in 1 BOTTLE

Product Details

After Care is a human over the counter drug product labeled by Merz North America. The generic name of After Care is dimethicone. The product's dosage form is cream and is administered via topical form.


What are After Care Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


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.

  • WATER (UNII: 059QF0KO0R)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • DECYL OLEATE (UNII: ZGR06DO97T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WHEAT GERM OIL (UNII: 14C97E680P)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • HUMAN SKIN PROTEINS, PARTIALLY HYDROLYZED (UNII: G9813R29TW)
  • MYRETH-3 MYRISTATE (UNII: O2C2MN32O6)
  • CETEARETH-12 (UNII: 7V4MR24V5P)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)
  • BORAGE SEED OIL (UNII: F8XAG1755S)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


* Please review the disclaimer below.

After Care Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Drug Facts

Distributed in the USA
by Merz North America, Inc.
Raleigh, NC 27615


Active Ingredients



Dimethicone 4%


Purpose



Skin protectant


Uses



  • Helps prevent, temporarily protect and relieve chapped or cracked skin.

Warnings



For external use only.


When Using This Product



  • Do not get into eyes

Stop Use And Ask A Doctor If



  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days

Do Not Use On



  • Deep or puncture wounds
  • Animal bites
  • Serious burns

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • Apply as needed.

Inactive Ingredients



Water (Aqua), Octyl-Dodecanol, Petrolatum, Hydrogenated Polyisobutene, Glyceryl Stearate, Decyl Oleate, Glycerin, Propylene Glycol, Wheat Germ (Triticum Vulgare) Oil, Stearic Acid, Cetyl Alcohol, Ceteareth-20, Processed Skin Proteins (PSP(R)), Myreth-3 Myristate, Ceteareth-12, Cetearyl Alcohol, Cetyl Palmitate, Wild Yam (Dioscorea Villosa) Root Extract, Borage (Borago Officinalis) Seed Oil, Tocopheryl Acetate, Glycosphingolipids, Carbomer, Methylparaben, Sodium Methylparaben, Ethylparaben, BHT, Phenoxyethanol, Disodium EDTA, Sodium Hydroxide, Propylparaben.


Other Information



  • Protect this product from excessive heat and direct sun.

Principal Display Panel - 15 Ml Bottle Carton



aftercare

POST-TREATMENT
SOOTHING CREAM

NEOCUTIS®


* Please review the disclaimer below.