benzoyl peroxide and sulfur
Dosage Form: gel
BPS Gel™
6% Benzoyl Peroxide
3% Sulfur
Rx Only
PRODUCT DESCRIPTION
BPS Gel™ is a topical preparation containing benzoyl peroxide 6% and sulfur 3%. The structural formula of benzoyl peroxide is as follows:
INACTIVE INGREDIENTS: Allantoin, Benzyl Alcohol NF, Carbomer 940 NF, Citric Acid (Anhydrous) USP, Colloidal Oatmeal, Disodium Oleamido MEA Sulfosuccinate, Edetate Disodium USP, Glycerin USP, Purified Water USP, Sodium Citrate USP.
BPS Gel - Clinical Pharmacology
The exact mode of action of benzoyl peroxide and sulfur in acne vulgaris is unknown but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. Benzoyl peroxide and sulfur are believed to exert a beneficial effect because of their antimicrobial activity and their mild keratolytic action.
INDICATIONS
BPS Gel™ is indicated in the treatment of acne vulgaris. See Directions section below for information on frequency and duration of medication use.
Contraindications
BPS Gel™ is contraindicated in persons who have shown hypersensitivity to benzoyl peroxide, sulfur, or to any of the other ingredients in the product.
FOR EXTERNAL USE ONLY. Keep out of reach of children. Keep away from eyes. Keep tube tightly closed.
Warnings
External Use Only. Not for ophthalmic Use. Avoid prolonged sun exposure, tanning booths, and sunlamps.
Precautions
BPS Gel™ is for external use only. Do not come in contact with eyes or mucous membranes (e.g., inside of nose) and any damaged areas of the skin, such as wounds or open sores. If accidental contact with one of these areas occurs, rinse thoroughly with water. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may be resumed with less frequent application. Avoid contact with hair, fabrics or carpeting as benzoyl peroxide will cause bleaching.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Pregnancy
Category C
Animal reproduction studies have not been conducted with BPS Gel™. It is also not known whether BPS Gel™ can cause fetal harm when administered to a pregnant woman. This product should be used only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
It is not known whether these drugs are excreted in human milk following topical use of BPS Gel™. However, because many drugs are excreted in human milk, caution should be exercised when administering this medication to a nursing woman.
Pediatric Use
Safety and effectiveness in children under 12 years of age has not been established.
Adverse Reactions
Contact sensitization reactions are associated with the use of topical benzoyl peroxide and sulfur products, and may be expected to occur in 10 to 25 out of 1,000 patients. The most frequent adverse reaction associated with benzoyl peroxide and sulfur use are excessive erythema (redness) and peeling which may be expected to occur in 5 out of every 100 patients. Excessive erythema (redness) and peeling most frequently appear during the initial phase of medication use and may normally be controlled by reducing frequency of use.
Directions
Cleanse affected areas. Apply the medication to the affected areas once a day during the first week, and twice a day thereafter as tolerated. Frequency of use should be adjusted to obtain the desired clinical response.
How is BPS Gel Supplied
BPS Gel™ (benzoyl peroxide 6% and sulfur 3%) is supplied in 43 g. tubes. NDC 51991-634-83.
Storage
Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F). See USP Controlled Room Temperature. Protect from freezing.
Dispense in original container.
WARNING: Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
Manufactured by: Groupe Parima Inc., Montréal, QC Canada H4S 1X6
Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487
Iss: 1/09
PRINCIPAL DISPLAY PANEL - 43 g Carton
Breckenridge
Pharmaceutical, Inc.
NDC 51991-634-83
BPS Gel™
6% Benzoyl Peroxide
3% Sulfur
Rx Only
Net Wt. 43 g
Acne Treatment Gel
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| UNAPPROVED DRUG OTHER | 11/01/2009 | 04/30/2011 | |
| Labeler - Breckenridge Pharmaceutical, Inc. (150554335) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Groupe Parima | 252437850 | MANUFACTURE | |
More BPS Gel resources
- BPS Gel Side Effects (in more detail)
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