Cetaphil Gentle Clear Bpo Acne Cleanser
Benzoyl Peroxide
Galderma Laboratories, L.p.
Human Otc Drug
NDC 0299-4125Cetaphil Gentle Clear Bpo Acne Cleanser also known as Benzoyl Peroxide is a human otc drug labeled by 'Galderma Laboratories, L.p.'. National Drug Code (NDC) number for Cetaphil Gentle Clear Bpo Acne Cleanser is 0299-4125. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Cetaphil Gentle Clear Bpo Acne Cleanser drug includes Benzoyl Peroxide - 2.6 g/100mL . The currest status of Cetaphil Gentle Clear Bpo Acne Cleanser drug is Active.
Drug Information:
| Drug NDC: | 0299-4125 |
| 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: | Cetaphil Gentle Clear Bpo Acne Cleanser |
| 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: | Galderma Laboratories, L.p. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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: | BENZOYL PEROXIDE - 2.6 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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 May, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 2025 |
| 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, 2023 |
| 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: | Galderma Laboratories, L.P.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1655910
|
| 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. |
| UPC: | 0302994125005
|
| UPC stands for Universal Product Code. |
| UNII: | W9WZN9A0GM
|
| 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 |
|---|
| 0299-4125-00 | 124 mL in 1 TUBE (0299-4125-00) | 01 May, 2022 | N/A | No |
| 0299-4125-05 | 12 mL in 1 TUBE (0299-4125-05) | 01 May, 2022 | 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
Product Elements:
Cetaphil gentle clear bpo acne cleanser benzoyl peroxide benzoyl peroxide benzoyl peroxide water magnesium aluminum silicate glycerin sodium c14-16 olefin sulfonate polyethylene glycol 3350 laureth-2 phenoxyethanol xanthan gum glycyrrhizinate dipotassium poloxamer 124 zinc gluconate edetate disodium citric acid monohydrate (052722) p55507-0 cetaphil gentle clear bpo cleanser 4.2oz tube
Indications and Usage:
Uses for the treatment of acne
Warnings:
Warnings for external use only. do not use if you â have very sensitive skin â are sensitive to benzoyl peroxide when using this product â 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. â avoid unnecessary sun exposure and use a sunscreen â avoid contact with the eyes, lips, and mouth â avoid contact with hair and dyed fabrics, which may be bleached by this product â 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 â irritation becomes severe
Dosage and Administration:
Directions â gently massage a dime-size amount onto dampened skin for 20 â 30 seconds, avoiding the eye area. rinse thoroughly and pat dry. can be used twice daily or as directed by a doctor. â if bothersome dryness or peeling occurs, reduce application to once a day or every other day. â if going outside, apply sunscreen after using this product. if irritation or sensitivity develops, stop use of both products and ask a doctor.
Package Label Principal Display Panel:
Principle display panel - 4.2 fl oz tube new #1 doctor recommended sensitive skincare brand cetaphil ® gentle clear complexion-clearing bpo acne cleanser 2.6 % benzoyl peroxide acne treatment micronized bpo starts clearing breakouts after first use without being harsh on sensitive skin zinc and licorice root reduce excess oil and soothe skin 5 skin sensitivity signs 4.2 fl oz (124 ml)
Further Questions:
Questions or comments? 1-866-735-4137
Distributed by: galderma laboratories, l.p. fort worth, tx 76177 usa all trademarks are the property of their respective owners made in canada cetaphil.com. p55507-0