DailyMed Label: BenzePrO

DailyMed Label: BenzePrO

2022

DailyMed Prescription

BenzePrO

Benzoyl Peroxide

PruGen, Inc.

NDC: 42546-016

NDC: 42546-016

NDC: 42546-016

BenzePrO ® Foaming Cloths are a topical preparation containing 6.0% benzoyl peroxide. Each gram of BenzePrO ® Foaming Cloths wash contains 60 mg of Benzoyl Peroxide as micronized particles. Ingredients include Purified Water, Carbomer 1342, Sodium Hyaluronate, Cetyl Alcohol, Glycerine, Hydroxypropyl Methylcellulose, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Lauryl Sulfoacetate and Disodium Laureth Sulfosuccinate, Sodium PCA, Sodium Hydroxide 10% Solution, Zinc Lactate, Citric Acid, Sodium Citrate, Benzoyl Peroxide 6.0%, Docusate Sodium. Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl peroxide (C 14 H 10 O 4 ) is represented by the following structure: Chemical Structure

BenzePrO ® Foaming Cloths are indicated for use in the topical treatment of mild to moderate acne vulgaris.

Avoid contact with hair, fabrics or carpeting as benzoyl peroxide will cause bleaching or discoloration. Wash affected areas once or twice daily, or as directed by your physician. Wet face with water. Wet cloth with a little waterand work into a full lather. Cleanse face with cloth for 10-20 seconds avoiding eyes. Rinse thoroughly and pat dry. Throw away cloth. Do not flush. If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

BenzePrO ® Foaming Cloths should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the product. Discontinue use if hypersensitivity is observed.

If severe irritation develops, discontinue use and institute appropriate therapy. This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. Avoid contact with eyes, eyelids, lips, and mucous membranes. If accidental contact occurs, rinse with water. If excessive redness or irritation develops, discontinue use and consult your physician. Based upon all available evidence, benzoyl peroxide is not considered to be a carcinogen. However, data from a study using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of the findings is not known. Category C animal reproduction studies have not been conducted with benzoyl peroxide. It is also 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. It is not known whether this drug is excreted in the human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman. Safety and effectiveness in children below the age of 12 have not been established.

Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.

BenzePrO ® Foaming Cloths are supplied in a carton containing 60 × 3.2 g individually wrapped benzoyl peroxide 6% foaming cloths (NDC 42546-016-60). Store at room temperature: 15° - 25°C (59° - 77°F). Protect from freezing.

The exact method of action of benzoyl peroxide in acne vulgaris is not known. Benzoyl peroxide is an antibacterial agent with demonstrated activity against Propionibacterium acnes. This action, combined with the mild keratolytic effect of benzoyl peroxide, is believed to be responsible for its usefulness in acne. Benzoyl peroxide is absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine.

NDC 42546-016-60 Rx only BenzePrO ® Foaming Cloths benzoyl peroxide 6.0% 60 cloths Net wt. 3.2 g each PRUGEN PHARMACEUTICALS PRINCIPAL DISPLAY PANEL - 60 Cloth Packet Carton