NDC 10812-130 Neutrogena Clinical Lifting Wrinkle Treatment System

Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone

NDC Product Code 10812-130

NDC CODE: 10812-130

Proprietary Name: Neutrogena Clinical Lifting Wrinkle Treatment System 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: Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone 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.

NDC Code Structure

  • 10812 - Johnson & Johnson Consumer Inc.
    • 10812-130 - Neutrogena Clinical Lifting Wrinkle Treatment System

NDC 10812-130-90

Package Description: 1 BOTTLE, PUMP in 1 KIT > 10 mL in 1 BOTTLE, PUMP

NDC Product Information

Neutrogena Clinical Lifting Wrinkle Treatment System with NDC 10812-130 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Neutrogena Clinical Lifting Wrinkle Treatment System is avobenzone, homosalate, octisalate, octocrylene, and oxybenzone. The product's dosage form is cream and is administered via topical form.

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 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.

Neutrogena Clinical Lifting Wrinkle Treatment System 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.


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: Johnson & Johnson Consumer Inc.
Labeler Code: 10812
FDA Application Number: part352 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: 04-15-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 12-01-2023 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Exclude Flag: N - NO 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".

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Neutrogena Clinical Lifting Wrinkle Treatment System Product Label Images

Neutrogena Clinical Lifting Wrinkle Treatment System 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

Otc - When Using

For external use only. Avoid contact with eyes. If contact occurs, flush thoroughly with water. Discontinue use if irritation or rash appear.

Otc - Keep Out Of Reach Of Children

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

Active Ingredients

Avobenzone 3%, Homosalate 12%, Octisalate 5%, Octocrylene 5%, Oxybenzone 3%

Inactive Ingredients

Water Butylene Glycol C12-15 Alkyl Benzoate Tetrahydroxypropyl Ethylenediamine Silica Cetearyl Alcohol Cyclopentasiloxane Dimethicone Steareth-2 Glyceryl Stearate Steareth-21 Aluminum Starch Octenylsuccinate Cetearyl Glucoside C13-14 Isoparaffin Dimethicone/Vinyl Dimethicone Crosspolymer Arachidyl Alcohol PEG-100 Stearate Disodium EDTA Polyacrylamide Behenyl Alcohol Acrylates/C10-30 Alkyl Acrylate Crosspolymer Propylparaben Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Arachidyl Glucoside Laureth-7 Citric Acid Benzyl Alcohol Phenoxyethanol Methylparaben Ethylparaben Fragrance

Questions

1-800-582-4048 or www.neutrogena.com

* Please review the disclaimer below.