Acne Free Severe Acne 24 Hr Acne Clearing System
Benzoyl Peroxide
Acnefree, Llc
Human Otc Drug
NDC 80861-010Acne Free Severe Acne 24 Hr Acne Clearing System also known as Benzoyl Peroxide is a human otc drug labeled by 'Acnefree, Llc'. National Drug Code (NDC) number for Acne Free Severe Acne 24 Hr Acne Clearing System is 80861-010. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Acne Free Severe Acne 24 Hr Acne Clearing System drug includes . The currest status of Acne Free Severe Acne 24 Hr Acne Clearing System drug is Active.
Drug Information:
| Drug NDC: | 80861-010 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Acne Free Severe Acne 24 Hr Acne Clearing System |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Benzoyl Peroxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Acnefree, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Dec, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part333D |
| 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. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | AcneFree, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 106310
845836
2048989
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 80861-010-01 | 1 KIT in 1 KIT (80861-010-01) * 118 mL in 1 BOTTLE (80861-004-01) * 59 mL in 1 BOTTLE (80861-011-01) | 01 Dec, 2017 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose acne treatment
Purpose acne treatment
Product Elements:
Acne free severe acne 24 hr acne clearing system benzoyl peroxide oil free acne cleanser benzoyl peroxide water glycerin propylene glycol cocamidopropyl hydroxysultaine sodium c14-16 olefin sulfonate xanthan gum citric acid monohydrate potassium hydroxide methyl methacrylate sodium lauroyl lactylate glycolic acid ceramide np ceramide ap phytosphingosine cholesterol carbomer homopolymer, unspecified type ceramide 1 benzoyl peroxide benzoyl peroxide maximum strength acne benzoyl peroxide water butylene glycol alkyl (c12-15) benzoate glycerin glyceryl monostearate peg-100 stearate cetostearyl alcohol phenoxyethanol polysorbate 60 dimethicone xanthan gum cetyl alcohol levomenol edetate sodium ethylhexylglycerin methylisothiazolinone benzalkonium chloride pseudopterogorgia elisabethae ginger chamomile alcohol leuconostoc/radish root ferment filtrate methylparaben edetate disodium anhydrous ethylparaben methyl methacrylate/glycol dimethacrylate crosspolymer benzoyl peroxide benzoyl peroxide
Indications and Usage:
Use for the treatment of acne
Use for the treatment of acne
Warnings:
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.
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.
Do Not Use:
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.
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.
When Using:
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.
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.
Dosage and Administration:
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
Directions ⢠clean the skin thoroughly before applying this product ⢠cover the entire affected area 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 or 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 day ⢠if going outside, apply sunscreen after using this product. if irritation or sensitivity develops, stop use of both products and ask a doctor.
Stop Use:
Stop use and ask a doctor if skin irritation becomes severe
Stop use and ask a doctor if skin irritation becomes severe
Package Label Principal Display Panel:
Kit 80861-010-01 kit02 kit03
80861-004-01 label08
80861-011-01 label09
Further Questions:
Questions or comments? 1-888-768-2913
Questions or comments? 1-888-768-2913