BENZEPRO- benzoyl peroxide cloth

BenzePrO by

Drug Labeling and Warnings

BenzePrO by is a Prescription medication manufactured, distributed, or labeled by PruGen, Inc., Span Packing Services. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rx Only

DESCRIPTION

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:

CLINICAL PHARMACOLOGY

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.

INDICATIONS AND USAGE

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

CONTRAINDICATIONS

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.

WARNINGS

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.

PRECAUTIONS

General

If severe irritation develops, discontinue use and institute appropriate therapy.

Information for patients

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

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.

Pregnancy

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.

Nursing Mothers

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.

Pediatric Use

Safety and effectiveness in children below the age of 12 have not been established.

ADVERSE REACTIONS

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

OVERDOSAGE

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.

DIRECTIONS

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.

HOW SUPPLIED

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.

SPL UNCLASSIFIED SECTION

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

Rev. 3.0

PRINCIPAL DISPLAY PANEL - 60 Cloth Packet Carton

NDC: 42546-016-60
Rx only

BenzePrO®

Foaming Cloths
benzoyl peroxide 6.0%

60
cloths
Net wt. 3.2 g each

PRUGEN
PHARMACEUTICALS

INGREDIENTS AND APPEARANCE

BENZEPRO 
benzoyl peroxide cloth

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 42546-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	60 mg

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: 809Y72KV36)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Cetyl Alcohol (UNII: 936JST6JCN)
Glycerin (UNII: PDC6A3C0OX)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
Sodium Cocoyl Isethionate (UNII: 518XTE8493)
Sodium Methyl Cocoyl Taurate (UNII: JVL98CG53G)
Sodium Lauryl Sulfoacetate (UNII: D0Y70F2B9J)
Disodium Laureth Sulfosuccinate (UNII: D6DH1DTN7E)
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)
Sodium Hydroxide (UNII: 55X04QC32I)
Zinc Lactate (UNII: 2GXR25858Y)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)
Docusate Sodium (UNII: F05Q2T2JA0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42546-016-60	60 in 1 CARTON	08/01/2015
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		08/01/2015

Labeler - PruGen, Inc. (929922750)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packing Services		557434805	MANUFACTURE(42546-016)