NDC 80861-013 Acne Free Oil Free Acne Cleanser 2.5 Benzoyl Peroxide
Benzoyl Peroxide Liquid Topical

Product Information

Acne Free Oil Free Acne Cleanser 2.5 Benzoyl Peroxide is a human over the counter drug product labeled by Acnefree Llc. The generic name of Acne Free Oil Free Acne Cleanser 2.5 Benzoyl Peroxide is benzoyl peroxide. The product's dosage form is liquid and is administered via topical form.

Product Code80861-013
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.
Acne Free Oil Free Acne Cleanser 2.5 Benzoyl Peroxide
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.
Benzoyl Peroxide
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 FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Acnefree Llc
Labeler Code80861
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.
12-01-2017
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 Acne Free Oil Free Acne Cleanser 2.5 Benzoyl Peroxide?


Product Packages

NDC 80861-013-01

Package Description: 237 mL in 1 BOTTLE, PLASTIC

Product Details

What are Acne Free Oil Free Acne Cleanser 2.5 Benzoyl Peroxide 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.
  • BENZOYL PEROXIDE 25 mg/mL - A peroxide derivative that has been used topically for BURNS and as a dermatologic agent in the treatment of ACNE and POISON IVY DERMATITIS. It is used also as a bleach in the food industry.

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:

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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
  • SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • METHYL METHACRYLATE (UNII: 196OC77688)
  • SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
  • GLYCOLIC ACID (UNII: 0WT12SX38S)
  • CERAMIDE NP (UNII: 4370DF050B)
  • CERAMIDE AP (UNII: F1X8L2B00J)
  • PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • CERAMIDE 1 (UNII: 5THT33P7X7)

* Please review the disclaimer below.

Acne Free Oil Free Acne Cleanser 2.5 Benzoyl Peroxide Labeling and Warnings

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.

Table of Contents



Active Ingredient



Benzoyl peroxide 2.5%


Purpose



Acne treatment


Use



for the treatment of acne


Warnings



For external use only


Do Not Use



if you

• have very sensitive skin
• are 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 the eyes, lips, and mouth
  • 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.

Stop Use And Ask A Doctor If



skin irritation becomes severe


Keep Out Of Reach Of Children.



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


Directions



  • use every morning and evening
  • apply a dime-size amount to damp skin and gently massage, avoiding the eye area
  • rinse well
  • use wash on entire affected area one to two times daily
  • because excessive drying of the skin may occur, start with washing once daily, then gradually increase to two times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce cleansing 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.
  • may be used on chest or back

Questions Or Comments?



water, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium C14-16 olefin sulfonate, xanthan gum, citric acid, potassium hydroxide, methyl methacrylate/glycol dimethacrylate crosspolymer, sodium lauroyl lactylate, glycolic acid, ceramide NP, ceramide AP, phytosphingosine, cholesterol, carbomer, ceramide EOP

1-888-768-2913


Pakage Labeling:




* Please review the disclaimer below.