NDC 46783-004 After Care

Dimethicone

NDC Product Code 46783-004

NDC Code: 46783-004

Proprietary Name: After Care Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.


Code Structure
  • 46783 - Merz North America
    • 46783-004 - After Care

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

NDC Product Information

After Care with NDC 46783-004 is a 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.

Labeler Name: Merz North America

Dosage Form: Cream - 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.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


After Care Active Ingredient(s)

Additional informationCallout TooltipWhat 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 4 mg/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • 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)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Merz North America
Labeler Code: 46783
FDA Application Number: part347 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 04-01-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

After Care Product Label Images

After Care 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

Other

Drug Facts

Distributed in the USAby 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 worsensSymptoms last more than 7 days or clear up and occur again within a few days

Do Not Use On

  • Deep or puncture woundsAnimal bitesSerious 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.

* Please review the disclaimer below.

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