NDC 62742-4093 Dermaclear Purity Cleanser Level Ii

Benzoyl Peroxide

NDC Product Code 62742-4093

NDC CODE: 62742-4093

Proprietary Name: Dermaclear Purity Cleanser Level Ii 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: Benzoyl Peroxide 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat mild to moderate acne. It may be used in combination with other acne treatments. When applied to the skin, benzoyl peroxide works by reducing the amount of acne-causing bacteria and by causing the skin to dry and peel. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

NDC Code Structure

  • 62742 - Allure Labs, Inc.
    • 62742-4093 - Dermaclear Purity Cleanser Level Ii

NDC 62742-4093-2

Package Description: 1 BOTTLE in 1 CARTON > 177.4 mL in 1 BOTTLE (62742-4093-1)

NDC Product Information

Dermaclear Purity Cleanser Level Ii with NDC 62742-4093 is a a human over the counter drug product labeled by Allure Labs, Inc.. The generic name of Dermaclear Purity Cleanser Level Ii is benzoyl peroxide. The product's dosage form is gel and is administered via topical form.

Labeler Name: Allure Labs, Inc.

Dosage Form: Gel - 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.

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.

Dermaclear Purity Cleanser Level Ii 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.

  • BENZOYL PEROXIDE 50 mg/mL

Inactive Ingredient(s)

About 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)
  • SORBITOL (UNII: 506T60A25R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
  • SILVER (UNII: 3M4G523W1G)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)
  • MENTHA PIPERITA LEAF (UNII: A389O33LX6)
  • PRIMULA VERIS (UNII: W6LFQ57E4M)
  • ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69)
  • VERONICA OFFICINALIS FLOWERING TOP (UNII: 9IH82J936J)
  • MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
  • ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
  • CARBOMER 934 (UNII: Z135WT9208)
  • OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
  • NORDIHYDROGUAIARETIC ACID, (+/-)- (UNII: 7PZ73W4ZNR)
  • LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3)

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: Allure Labs, Inc.
Labeler Code: 62742
FDA Application Number: part333D 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: 11-28-2017 What 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: 12-31-2021 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Dermaclear Purity Cleanser Level Ii Product Label Images

Dermaclear Purity Cleanser Level Ii 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 Ingredient: Benzoyl Peroxide - 5%

Otc - Purpose

Purpose: Anti-acne

Indications & Usage

Uses: For the treatment and management of mild acne.

Warnings

Warning: For external use only.

Otc - Do Not Use

  • Do not use if youHave very sensitive skin.Are sensitive to benzoyl peroxide.

Otc - When Using

  • When using this productAvoid contact with eyes, lips and mouth.Avoid contact with hair and dyed fabric, which may be bleached by this product.

Otc - Stop Use

  • Stop use and ask a doctorIf severe skin irritation occurs.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

  • DirectionEmulsify cleanser with lukewarm water and gently massage onto the skin.Rinse well and pat dry.Not recommended for those with nut allergies.

Inactive Ingredient

Water (Aqua), Sorbitol, Cetyl Alcohol, Stearyl Alcohol, Propylene Glycol, Glycerin, Ammonium Lauryl Sulfate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Dimethyl Sulfone, PPG-12/ SMDI Copolymer, Disodium EDTA, Melia Azadirachta Leaf Extract, Silver, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Salix Alba (Willow) Bark Extract, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Butylene Glycol, PEG-60 Almond Glycerides, Carbomer, Nordihydroguaiaretic Acid, Oleanolic Acid, Leptospermum Scoperium Branch/ Leaf Oil.

* Please review the disclaimer below.