Label: BENZEPRO CREAMY WASH- benzoyl peroxide soap
- NDC Code(s): 42546-017-18
- Packager: PruGen, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated July 5, 2018
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- SPL UNCLASSIFIED SECTION
BenzePrOTM Creamy Wash is intended for topical administration and contains Benzoyl Peroxide for use in the treatment of acne vulgaris. Benzoyl Peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl Peroxide (C14H10O4) is represented by the following chemical structure:
Each gram of BenzePrOTM Creamy Wash contains 70 mg of Benzoyl Peroxide as microsphere particles (via Curoxyl® 42) in an emulsion based formulation consisting of: aloe, carbomer 940, cetyl alcohol, disodium oleamido MEA-sulfosuccinate, disodium EDTA, glyceryl stearate/PEG-100 stearate, glycerin, green tea, laureth-12, magnesium aluminum silicate, propylene glycol, purified water, sodium coco-sulfate, sodium lauroamphoacetate, xanthan gum.
The mechanism of action of Benzoyl Peroxide is not totally understood but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. In addition, patients treated with Benzoyl Peroxide show a reduction in lipids and free fatty acids, and mild desquamation (drying and peeling activity) with simultaneous reduction in comedones and acne lesions. Little is known about the percutaneous penetration, metabolism, and excretion of Benzoyl Peroxide, although it has been shown that Benzoyl Peroxide absorbed by the skin is metabolized to benzoic acid and then excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by Benzoyl Peroxide in humans.
- INDICATIONS AND USAGE:
Do not use if you:
- have very sensitive skin
- are sensitive to benzoyl peroxide
When using this product:
- 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:
- irritation becomes severe
- have very sensitive skin
INFORMATION FOR PATIENTS:
General: If accidental contact occurs with eyes, mouth, or mucous membranes, rinse with water.
Carcinogensesis, Mutagenesis, Impairment of Fertility:
Data from several studies employing a strain of mice that is highly susceptible to developing cancer suggest that Benzoyl Peroxide acts as a tumor promoter. The clinical significance of these findings to humans is unknown. Benzoyl Peroxide has not been found to be mutagenic (Ames Test) and there are no published data indicating it impairs fertility.
Teratogenic Effects: Pregnancy Category C: Animal reproduction studies have not been conducted with Benzoyl Peroxide. It is not known whether Benzoyl Peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl Peroxide should be used by a pregnant woman only if clearly needed. There are no available data on the effect of Benzoyl Peroxide on the later growth, development and functional maturation of the unborn child.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Benzoyl Peroxide is administered to a nursing woman.
- ADVERSE REACTIONS:
If excessive scaling, erythema or edema occurs, the use of this preparation should be discontinued. To hasten resolution of the adverse effects, cool compresses may be used. After symptoms and signs subside, a reduced dosage schedule may be cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.
DOSAGE AND ADMINISTRATION:
BenzePrOTM Creamy Wash: Apply to affected areas once or twice a day, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10-20 seconds, working into a full lather. Rinse thoroughly and pat dry. If excessive drying occurs, control by rinsing off cleanser sooner or using less often.
- If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
BenzePrO™ Creamy Wash is supplied in a 180 g bottle (NDC 42546-017-18).
Store at controlled room temperature 20°-25° C (68°-77° F); excursions permitted to 15°-30°C (59°-86°F).
Protect from freezing.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
PruGen, Inc. Pharmaceuticals
18899 North Thompson Peak Parkway
Scottsdale, AZ 85255
- PRINCIPAL DISPLAY PANEL - 180 g Tube Label
INGREDIENTS AND APPEARANCE
BENZEPRO CREAMY WASH
benzoyl peroxide soap
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42546-017 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 7 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE (UNII: V5VD430YW9) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) CETYL ALCOHOL (UNII: 936JST6JCN) DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATE (UNII: 5M1101WGSY) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) GREEN TEA LEAF (UNII: W2ZU1RY8B0) LAURETH-12 (UNII: OAH19558U1) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM COCO-SULFATE (UNII: 3599J29ANH) SODIUM LAUROAMPHOACETATE (UNII: SLK428451L) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42546-017-18 180 g in 1 TUBE; Type 0: Not a Combination Product 07/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 07/01/2015 Labeler - PruGen, Inc. (929922750) Establishment Name Address ID/FEI Business Operations PHARMASOL CORPORATION 065144289 MANUFACTURE(42546-017)