NDC 56152-4012 Anti Bac Acne Clearing

Benzoyl Peroxide

NDC Product Code 56152-4012

NDC Product Information

Anti Bac Acne Clearing with NDC 56152-4012 is a a human over the counter drug product labeled by Cosmetic Enterprise Ltd. The generic name of Anti Bac Acne Clearing is benzoyl peroxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Cosmetic Enterprise Ltd

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.


Anti Bac Acne Clearing 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.

  • BENZOYL PEROXIDE 5 g/100mL

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.

  • PEG-40 STEARATE (UNII: ECU18C66Q7)
  • WATER (UNII: 059QF0KO0R)
  • PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)
  • SERENOA REPENS WHOLE (UNII: 487DXM62F2)
  • SESAME SEED (UNII: 7Y1255HVXR)
  • SODIUM ASCORBATE (UNII: S033EH8359)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
  • METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • CERAMIDE NS DILAURATE (UNII: 1SL625KAAV)
  • CERAMIDE NP (UNII: 4370DF050B)
  • OLEIC ACID (UNII: 2UMI9U37CP)
  • PALMITIC ACID (UNII: 2V16EO95H1)

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: Cosmetic Enterprise Ltd
Labeler Code: 56152
FDA Application Number: part333D 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: 01-14-2019 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’.

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Information for Patients

Benzoyl Peroxide Topical

Benzoyl Peroxide Topical is pronounced as (ben' zoe il)

Why is benzoyl peroxide topical medication prescribed?
Benzoyl peroxide is used to treat mild to moderate acne....
[Read More]

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Anti Bac Acne Clearing Product Label Images

Anti Bac Acne Clearing 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 - Active Ingredient

Active IngredientBenzoyl Peroxide 5%PurposeAcne Treatment

Otc - Purpose

  • UseFor the treatment of acneHelps keep skin clear of new acne blemishes

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.

Indications & Usage

Stop use and ask a doctor if irritation becomes severe.

Warnings

  • WarningsFor external use onlyWhen using this productUsing other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.Do not use this product if you have very sensitive skin or if you are sensitive to Benzoyl Peroxide.Avoid unnecesary sun exposure and use a sunscreenAvoid contact with the eyes, lips, and mouth.Avoid contact with hair and dyed fabrics, which may be bleached by this productSkin irritation may occur, characterized by redness, burning, itching, peeling, or possible swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Dosage & Administration

  • DirectionsClease Skin thoroughly before applying. Cover the affected area with a thin layer 1 to 3 days. Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. If going outside apply sunscreen after using this product. If irritation or sensitivity develops, stop use of products and ask a doctor.

Inactive Ingredient

Inactive IngredientsWater/Aqua/Eau, PPG-2 Myristyl Ether Propionate, Argania Spinosa Kernel Extract, PEG-40 Sterate, Serenoa Serrulata Fruit Extract, Sesamum Indicum (sesame) Seed Extract, Alcohol Denat., Sorbitan Stearate, Hydrogenated Methyl Abeitate, Methyl Methacrylate Crosspolymer, Carbomer, Glyceryl Stearate, Cetyl Alcohol, Tetrasodium EDTA, Hydrogenated Lecithin, Cholesterol, Ceramide NS, Ceramide NP, Oleic Acid, Plamitic Acid, Sodium Ascorbate, Sodium Hydroxide, EDTA, Ethylhexylglycerin, Phenoxyethanol

* Please review the disclaimer below.

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