NDC 64760-732 Glytone Acne Bpo Treatment Gel

Benzoyl Peroxide

NDC Product Code 64760-732

NDC CODE: 64760-732

Proprietary Name: Glytone Acne Bpo Treatment Gel 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

  • 64760 - Pierre Fabre Usa Inc.

NDC 64760-732-01

Package Description: 1 BOTTLE in 1 CARTON > 1 GEL in 1 BOTTLE

NDC Product Information

Glytone Acne Bpo Treatment Gel with NDC 64760-732 is a a human over the counter drug product labeled by Pierre Fabre Usa Inc.. The generic name of Glytone Acne Bpo Treatment Gel is benzoyl peroxide. The product's dosage form is gel and is administered via topical form.

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.

Glytone Acne Bpo Treatment Gel 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.


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.

  • GRAPEFRUIT SEED OIL (UNII: 598D944HOL)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • PEG-40 STEARATE (UNII: ECU18C66Q7)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
  • ARCTIUM LAPPA ROOT OIL (UNII: 55DGS3F5YG)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • DOCUSATE SODIUM (UNII: F05Q2T2JA0)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CARBOMER 1342 (UNII: 809Y72KV36)
  • SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • WATER (UNII: 059QF0KO0R)

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: Pierre Fabre Usa Inc.
Labeler Code: 64760
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: 09-01-2021 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: 12-31-2022 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 - 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".

* Please review the disclaimer below.

Glytone Acne Bpo Treatment Gel Product Label Images

Glytone Acne Bpo Treatment Gel 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

Purpose

Acne Treatment

Active Ingredient

Benzoyl Peroxide 5%

Use

For the treatment of Acne.Dries and clears acne blemishes and allows skin to heal.Penetrates pores to eliminate most acne blemishes, blackheads and whiteheads.Helps prevent the development of new acne blemishes, blackheads and whiteheads.

Warnings

For external use only.

Do Not Use If You

Have very sensitive skinare sensitive to benzoyl peroxide

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.avoid unnecessary sun exposure and use a sunscreen.avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.avoid contact with hair and dyed fabrics, which may be bleached by this product.skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Keep Out Of Reach Of Children.

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

Directions

Cleanse the skin thoroughly before applying product.Cover the affected area(s) with a thin layer one to three times daily.Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily or as directed by your physician.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 both products and ask a doctor.

Other Information

Store at room temperature of 68-77 F (22-25 C).

Inactive Ingredients

Water (AQUA), PROPANEDIOL, DIMETHYL ISOSORBIDE, BUTYLENE GLYCOL, GLYCERIN, 1,2-HEXANEDIOL, ACRYLAMIDE/SODIUM ACRYLOYL-DIMETHYLTAURATE COPOLYMER, ISOHEXADECANE, HYDROXYACE-TOPHENONE, POLYSORBATE 80, POLYGLYCERYL-2 ISOSTEARATE, XANTHAN GUM, ENANTIA CHLORANTHA BARK EXTRACT, SODIUM CITRATE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, CITRIC ACID, DIETHYLHEXYL SODIUM SULFOSUCCINATE, CARBOMER, SODIUM HYDROXIDE, ETHYLHEXYL-GLYCERIN, CITRUS GRANDIS (GRAPEFRUIT) SEED EXTRACT, ECHINACEA ANGUSTIFOLIA EXTRACT, DIMETHICONE, ARCTIUM LAPPA ROOT EXTRACT, PHENOXYETHANOL, OLEANOLIC ACID, PEG-40 STEARATE, SILICA, SORBITAN STEARATE, TOCOPHEROL

* Please review the disclaimer below.