NDC 49967-138 Cerave Developed With Dermatologists Acne Control Cleanser
Salicylic Acid Gel Topical

Product Information

What is NDC 49967-138?

The NDC code 49967-138 is assigned by the FDA to the product Cerave Developed With Dermatologists Acne Control Cleanser which is a human over the counter drug product labeled by L'oreal Usa Products Inc. The generic name of Cerave Developed With Dermatologists Acne Control Cleanser is salicylic acid. The product's dosage form is gel and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 49967-138-01 237 ml in 1 tube , 49967-138-02 10 ml in 1 tube . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code49967-138
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.		Cerave Developed With Dermatologists Acne Control Cleanser
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.		Salicylic Acid
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 FormGel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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.		L'oreal Usa Products Inc
Labeler Code49967
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.		part333D
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.		08-11-2021
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.		12-31-2023
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

What are the uses for Cerave Developed With Dermatologists Acne Control Cleanser?


Product Packages

NDC Code 49967-138-01

Package Description: 237 mL in 1 TUBE

NDC Code 49967-138-02

Package Description: 10 mL in 1 TUBE

Product Details

What are Cerave Developed With Dermatologists Acne Control Cleanser Active Ingredients?

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.
  • SALICYLIC ACID 20 mg/mL - A compound obtained from the bark of the white willow and wintergreen leaves. It has bacteriostatic, fungicidal, and keratolytic actions.

Cerave Developed With Dermatologists Acne Control Cleanser Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Cerave Developed With Dermatologists Acne Control Cleanser Inactive Ingredients UNII Codes

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.

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Cerave Developed With Dermatologists Acne Control Cleanser Product Label

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.

Product Label Table of Contents



Active Ingredient



Salicylic acid 2%


Purpose



Acne treatment


Uses



  • clears acne blemishes and allows skin to heal
  • helps prevent new acne blemishes from forming

Warnings



For external use only


When Using This Product



skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical acne medication at a time.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • use twice daily
  • shake well, wet face, then work product into a lather
  • massage onto face avoiding the eyes
  • rinse well

Inactive Ingredients



water, sodium lauroyl sarcosinate, cocamidopropyl hydroxysultaine, glycerin, niacinamide, gluconolactone, sodium methyl cocoyl taurate, PEG-150 pentaerythrityl tetrastearate, xanthan gum, sodium benzoate, sodium hydroxide, hectorite, trisodium ethylenediamine disuccinate, sodium lauroyl lactylate, tetrasodium EDTA, calcium gluconate, ceramide NP, triethyl citrate, caprylyl glycol, ceramide AP, phytosphingosine, cholesterol, hydrolyzed hyaluronic acid, carbomer, benzoic acid, ceramide EOP


Package Label.Principal Display Panel



image of a label - CVAcneControlCleanserFront

image of a label - CVAcneControlCleanserFront


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