NDC 76209-354 Timeless Prescription - Acne Repairing Step 3

Benzoyl Peroxide

NDC Product Code 76209-354

NDC CODE: 76209-354

Proprietary Name: Timeless Prescription - Acne Repairing Step 3 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

  • 76209 - Market America, Inc.
    • 76209-354 - Timeless Prescription - Acne Repairing

NDC 76209-354-23

Package Description: 59 mL in 1 BOTTLE, DISPENSING

NDC Product Information

Timeless Prescription - Acne Repairing Step 3 with NDC 76209-354 is a a human over the counter drug product labeled by Market America, Inc.. The generic name of Timeless Prescription - Acne Repairing Step 3 is benzoyl peroxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Market America, Inc.

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 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.

Timeless Prescription - Acne Repairing Step 3 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 2.5 g/100mL

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)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • LAURETH-7 (UNII: Z95S6G8201)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • ALLANTOIN (UNII: 344S277G0Z)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • NORDIHYDROGUAIARETIC ACID, (+/-)- (UNII: 7PZ73W4ZNR)
  • OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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: Market America, Inc.
Labeler Code: 76209
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: 02-01-2021 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 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.

Timeless Prescription - Acne Repairing Step 3 Product Label Images

Timeless Prescription - Acne Repairing Step 3 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

Active Ingredient

BENZOYL PEROXIDE 2.5%

Purpose

ACNE TREATMENT

Uses

  • FOR THE TREATMENT OF ACNE

Warnings

  • FOR EXTERNAL USE ONLY.WHEN USING THIS PRODUCTAVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREENAVOID CONTACT WITH THE EYES, LIPS AND MOUTHAVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THIS PRODUCTSKIN 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.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.DO NOT USE IF YOUHAVE VERY SENSITIVE SKINARE SENSITIVE TO BENZOYL PEROXIDESTOP USE AND ASK A DOCTOR IFIRRITATION BECOMES SEVERE

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.

Directions

  • CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING THIS PRODUCTCOVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES DAILYBECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY, THEN GRADUALLY INCREASE TO TWO TO THREE TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR.IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAYIF GOING OUTSIDE, APPLY SUNSCREEN AFTER USING THIS PRODUCT. IF IRRITATION OR SENSITIVITY DEVELOPS, STOP USE OF ALL PRODUCTS AND ASK A DOCTOR.

Inactive Ingredients

WATER, CYCLOPENTASILOXANE, ACRYLATES COPOLYMER, BUTYLENE GLYCOL, GLYCERYL STEARATE, PEG-100 STEARATE, DIMETHICONE, CETEARYL ALCOHOL, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, CETEARETH-20, ALLANTOIN, PANTHENOL, BISABOLOL, PEG-60 ALMOND GLYCERIDES, CAPRYLYL GLYCOL, GLYCERIN, CARBOMER, NORDIHYDROGUAIARETIC ACID, OLEANOLIC ACID, PHENOXYETHANOL, METHYLISOTHIAZOLINONE, SODIUM HYDROXIDE

* Please review the disclaimer below.