Indications and uses
Cleanse & Treat is indicated for the topical treatment of acne vulgaris.
Clease and Treat
- Manufacturer
- Quinnova Pharmaceuticals, Inc.
- Effective date
- 2009-12-11
- Label type
- NON-STANDARDIZED ALLERGENIC LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:47:25
Label at a glance#
ProductClease and Treat
Active ingredientBENZOYL PEROXIDE, SELENIUM SULFIDE
Label structure10 sections
Dosage and administration
Unless otherwise directed by a prescribing physician, patients should apply one salicylic acid pad and one benzoyl peroxide pad to affected areas twice per day. Cleanse & Treat is a leave-on acne treatment, intended for use without water or additional cleansers unless otherwise directed by your physician.
Contacts and useful links#
Websitewww.quinnova.com
www.QUINNOVA.com
www.QUINNOVA.comLabel contents#
Full prescribing information#
DESCRIPTION
Cleanse & Treat
(benzoyl peroxide pad and salicylic acid pad)
Rx Only
Cleanse & Treat contains two separate and distinct non-woven pads enclosed in a heat-sealed foil pack compartmentalized from one another within the foil pack by filmstock. One non-woven pad bears a preparation consisting of 5% benzoyl peroxide and the following inactive ingredients: ammonium lauryl sulfate, carbomer, disodium cocoamphodiacetate, DMDM hydantoin, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium chloride, sodium hydroxide. The other non-woven pad bears a preparation consisting of 2% salicylic acid and the following inactive ingredients: ammonium lauryl sulfate, cellulose gum, disodium ricinoleamido MEA-sulfosuccinate, DMDM hydantoin, propylene glycol monoricinoleate, purified water, sodium citrate dihydrate.
CHEMICAL STRUCTURE
Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. It has an empirical formula of C14H10O4 with a molecular weight of 242.23. Benzoyl peroxide has the following molecular structure:
Salicylic acid is the 2 hydroxy derivative of benzoic aid. It has an empirical formula of C7H6O3 with a molecular weight of 138.12. Salicylic acid has the following molecular structure:
CLINICAL PHARMACOLOGY
The exact method of action of benzoyl peroxide in acne vulgaris is not known, however, its antibacterial activity against Propionibacterium acnes, together with its mild keratolytic effect, is believed to be its significant mode of action.
PEDIATRIC USE SECTION
Pediatric Use - Cleanse & Treat should not be used by children under 12 years of age.
INFORMATION FOR PATIENTS SECTION
Information for Patients - Patients should avoid unnecessary sun exposure and use a sunscreen when in sunlight. Contact with hair, fabrics, or any colored materials may result in bleaching or discoloration. Patients should avoid concomitant use of other drugs that may contribute to elevated serum salicylate levels where the potential for toxicity exists. Symptoms of salicylate toxicity may include nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea and diarrhea. In the event of salicylate toxicity, the use of Cleanse & Treat should be discontinued, fluids should be administered to promote urinary excretion and medical assistance should be obtained immediately.
SPL UNCLASSIFIED SECTION
Carcinogenesis, Mutagenesis, Impairment of Fertility - Data from some studies using a strain of mice highly susceptible to eveloping cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is not known. Benzoyl peroxide has not been found to be mutagenic in the Ames Salmonella Test and there are no published data suggesting that it impairs fertility. No data are available concerning potential carcinogenic or reproductive effects of salicylic acid. It has not been found to be mutagenic in the Ames Salmonella Test and there are no published data suggesting that it impairs fertility.
PREGNANCY SECTION
Pregnancy (Category C) - Animal reproduction studies have not been performed with benzoyl peroxide and it is not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman. Nevertheless, benzoyl peroxide should be used by a pregnant woman only if necessary. Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent 10 times or more the maximum daily human dose of salicylic acid when applied topically as directed with Cleanse &Treat. There are no adequate and well-controlled studies in pregnant women. Nevertheless, salicylic acid should be used by a pregnant woman only if necessary.
INDICATIONS AND USAGE
Cleanse & Treat is indicated for the topical treatment of acne vulgaris.
CONTRAINDICATIONS
Cleanse & Treat is contraindicated in patients with a history of hypersensitivity to any of its ingredients.
ADVERSE REACTIONS
Allergic contact dermatitis and/or dryness have been reported with topical benzoyl peroxide and salicylic acid, both when used separately and in combination with one another.
OVERDOSAGE
If excessive scaling, erythema or edema occurs, patients should discontinue use of Cleanse & Treat and consult with their physician.
DOSAGE AND ADMINISTRATION
Unless otherwise directed by a prescribing physician, patients should apply one salicylic acid pad and one benzoyl peroxide pad to affected areas twice per day. Cleanse & Treat is a leave-on acne treatment, intended for use without water or additional cleansers unless otherwise directed by your physician.
HOW SUPPLIED
Each Cleanse & Treat packette consists of one 0.8 g. 5% benzoyl peroxide pad and one 0.5 g. 2% salicylic acid pad, with each pad separated from one another by filmstock and both pads enclosed together in an individual heat-sealed foil pack bearing the NDC Number 23710-052-02.
Store at 15°-25° C (59°-77° F)
REFERENCES
Cleanse & Treat covered by US Patents: 5,254,109; 5,417,674; and 5,562,642.
Quinnova Pharmaceuticals, Inc., Newtown, PA 18940, (877) 660-6263, www.QUINNOVA.com.
Prescribing Information as of April 2008.
Pouch
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 999477 | {1 (benzoyl peroxide 50 MG/ML Medicated Pad) / 1 (salicylic acid 20 MG/ML Medicated Pad) } Pack [Cleanse and Treat] | BPCK | 2 |
| 999473 | {1 (benzoyl peroxide 50 MG/ML Medicated Pad) / 1 (salicylic acid 20 MG/ML Medicated Pad) } Pack | GPCK | 2 |
| 904807 | benzoyl peroxide 5 % Medicated Pad | PSN | 2 |
| 999477 | Cleanse and Treat Medicated Pad Pack | PSN | 2 |
| 999473 | salicyclic acid 2 % Medicated Pad (1) / benzoyl peroxide 5 % Medicated Pad (1) Pack | PSN | 2 |
| 797892 | salicylic acid 2 % Medicated Pad | PSN | 2 |
| 904807 | benzoyl peroxide 50 MG/ML Medicated Pad | SCD | 2 |
| 797892 | salicylic acid 20 MG/ML Medicated Pad | SCD | 2 |
| 904807 | benzoyl peroxide 5 % Medicated Pad | SY | 2 |
| 999473 | benzoyl peroxide 5 % Medicated Pad / Salicylic Acid 2 % Medicated Pad | SY | 2 |
| 999477 | Cleanse and Treat (benzoyl peroxide 5 % Medicated Pad (1) / salicylic acid 2 % Medicated Pad (1) ) Pack | SY | 2 |
| 797892 | salicylic acid 2 % Medicated Pad | SY | 2 |
| 797892 | salicylic acid 2 % Topical Swab | SY | 2 |
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| b382b4e1-6b48-45f6-bffc-e61b00b0ce19 | Product name | 3 | 20250317 |
| d9d61457-6a5a-41fc-b418-e5479a2904b7 | Product name | 2 | 20230303 |
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| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 4a7d44fe-774d-404b-aad0-8a90fe78375a | Product name | 4 | 20211025 |
| 3f45980c-c196-47e5-0e5e-48b7c57327c5 | Product name | 5 | 20200428 |
| d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27b | Product name | 3 | 20200203 |
| ee5c6de5-d9cd-454f-b250-7b19e5cf2992 | Product name | 4 | 20190619 |
| ad75fcfd-a339-42a1-9c60-43ba2c654cfa | Product name | 1 | 20170810 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 23710-052-02 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c336-621f-e053-dbdaa90a74ad | CLEANSE AND TREAT |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 23710-052-02 | Clease and Treat | 5 g in 1 POUCH | CLOTH | 5 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 23710-052-02 | EA - Each | 23710-052 | 7d307240-841b-4f3c-972d-c3bad38fcc7b | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BENZOYL PEROXIDE | ACTIVE INGREDIENT | W9WZN9A0GM | 2 | |
| SELENIUM SULFIDE | ACTIVE INGREDIENT | Z69D9E381Q | 2 | |
| BENZOYL PEROXIDE | ACTIVE MOIETY | W9WZN9A0GM | 2 | |
| SELENIUM | ACTIVE MOIETY | H6241UJ22B | 2 | |
| AMMONIUM LAURYL SULFATE | INACTIVE INGREDIENT | Q7AO2R1M0B | 2 | |
| CARBOMER 934 | INACTIVE INGREDIENT | Z135WT9208 | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| GLYCERYL RICINOLEATE | INACTIVE INGREDIENT | ZUE0CEL42O | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 2 | |
| POWDERED CELLULOSE | INACTIVE INGREDIENT | SMD1X3XO9M | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 2 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Products#
Every source-derived product name is available through these pages.
- Clease and Treat
- benzoyl peroxide pad and salicylic acid pad
- BENZOYL PEROXIDE
- SELENIUM SULFIDE
- SELENIUM
- AMMONIUM LAURYL SULFATE
- CARBOMER 934
- GLYCERIN
- METHYLPARABEN
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SODIUM CHLORIDE
- SODIUM HYDROXIDE
- POWDERED CELLULOSE
- GLYCERYL RICINOLEATE
- TRISODIUM CITRATE DIHYDRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 23710-052 | 23710-052-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / SUBCUTANEOUS | 0.7 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | IMPLANT / SUBCUTANEOUS | 77 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBCUTANEOUS | 31.45 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SUSPENSION / ORAL | 5013 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SPRAY, METERED / NASAL | 36 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION, CONCENTRATE / ORAL | 0.2 mg/1ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / OPHTHALMIC | 0.6 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SOLUTION / TOPICAL | 186 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / RESPIRATORY (INHALATION) | 0.01 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GEL / OPHTHALMIC | 0.9 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / ORAL | 64 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / ORAL | 400 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR | ADJ PH | ||
| CARBOMER 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | SUSPENSION/ DROPS / OPHTHALMIC | 0.4 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | FILM, SOLUBLE / ORAL | 11 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRADERMAL | ADJ PH | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, FILM COATED / ORAL | 100 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAVENOUS | 2.78 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / SUBARACHNOID | 0.9 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | DROPS / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | TABLET, DELAYED RELEASE / ORAL | 640 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | GEL / VAGINAL | 2 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / INTRAMUSCULAR | ADJ PH | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 0.86 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRASPINAL | ADJ PH | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACARDIAC | 70 mg | ||
| CARBOMER 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | CREAM / TOPICAL | 600 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRASYNOVIAL | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / AURICULAR (OTIC) | 0.01 %w/w | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SOLUTION / INTRAVENOUS | 41 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SOLUTION / OPHTHALMIC | 0.9 %w/w | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SOLUTION / OPHTHALMIC | 0.45 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / ORAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | AEROSOL, FOAM / TOPICAL | ADJ PH | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CONCENTRATE / ORAL | 2.5 mg/5ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS | 0.86 %w/v | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | TABLET / ORAL | 1582 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRATHECAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SOFT TISSUE | 0.15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | POWDER / RESPIRATORY (INHALATION) | ADJ PH | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / EPIDURAL | 0.9 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INFILTRATION | 648 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 24 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SUSPENSION/ DROPS / OPHTHALMIC | 7 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SUSPENSION / INTRAMUSCULAR | 1 mg |
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OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.