Label: BENZEPRO- benzoyl peroxide cloth

Rx Only

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 (C14H10O4) is represented by the following structure:

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.

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

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.

FOR EXTERNAL USE ONLY. Not For Ophthalmic Use. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

When using this product, skin irritation and dryness is more likely to occur if:

• you leave BenzePrO® Foaming Cloths on your skin longer than directed
• you use another topical acne medication at the same time

Do not use this product 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, 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 lower concentration.

Stop use and ask a doctor:

• if irritation becomes severe.

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

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.

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.

1. Wet face with water.
2. Wet cloth with a little waterand work into a full lather.
3. Cleanse face with cloth for 10-20 seconds avoiding eyes.
4. Rinse thoroughly and pat dry.
5. 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 are supplied in a carton containing 60 × 3.2 g individually wrapped benzoyl peroxide 6% foaming cloths (NDC 42546-016-60).

Manufactured for:
PruGen Pharmaceuticals
18899 N Thompson Peak Pkwy
Scottsdale, AZ 85255
www.prugen.com

Rev. 3.0

NDC 42546-016-60
Rx only

BenzePrO®

Foaming Cloths
benzoyl peroxide 6.0%

60
cloths
Net wt. 3.2 g each

PRUGEN
PHARMACEUTICALS