BPS Gel

Rx Only

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.

External Use Only. Not for ophthalmic Use. Avoid prolonged sun exposure, tanning booths, and sunlamps.

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

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad skin irritation.

Applies to benzoyl peroxide / sulfur topical: topical gel, topical lotion

Dermatologic

Excessive erythema and peeling occur most often during the initial phase of drug use and may be controlled by reducing the frequency of application.[Ref]

Dermatologic side effects have most frequently included excessive erythema and peeling (5%).[Ref]

Hypersensitivity

Hypersensitivity reactions in the form of contact sensitization have been reported and are expected to occur in 1% to 2.5% of patients.[Ref]

Some side effects of BPS Gel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.