TRIAZ® (benzoyl peroxide) 3%, 6%, & 9% Foaming Cloths

TRIAZ - benzoyl peroxide cloth 
Medicis Pharmaceutical Corp.

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TRIAZ®
(benzoyl peroxide) 3%, 6%, & 9%
Foaming Cloths

Rx Only

DESCRIPTION

TRIAZ (benzoyl peroxide) 3%, 6%, and 9% Foaming Cloths are topical preparations containing 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:

Chemical Structure

TRIAZ 3% and 6% Foaming Cloths contain, respectively, benzoyl peroxide 3% and 6% as the active ingredient in a cleanser-based formulation consisting of: purified water USP, sodium cocoyl isethionate, sodium methyl cocoyl taurate, cetyl alcohol NF, sodium lauryl sulfoacetate and disodium laureth sulfosuccinate, carbomer 1342 NF, sodium hydroxide NF, glycolic acid, hydroxypropyl methylcellulose, zinc lactate, sodium PCA, glycerin USP, docusate sodium USP, sodium hyaluronate, and simethicone USP.

TRIAZ 9% Foaming Cloths contains benzoyl peroxide 9% as the active ingredient in a cleanser-based formulation consisting of: puried water USP, sodium cocoyl isethionate, sodium methyl cocoyl taurate, cetyl alcohol NF, sodium lauryl sulfoacetate and disodium laureth sulfosuccinate, carbomer copolymer type B NF, glycolic acid, sodium hydroxide NF, hydroxypropyl methylcellulose, zinc lactate, sodium PCA, glycerin USP, docusate sodium USP, sodium hyaluronate, and simethicone USP.

CLINICAL PHARMACOLOGY

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

TRIAZ 3%, 6%, and 9% Foaming Cloths are indicated for the topical treatment of acne vulgaris.

CONTRAINDICATIONS

These preparations are contraindicated in patients with a history of hypersensitivity to any of their components.

WARNINGS

When using this product, avoid unnecessary sun exposure and use a sunscreen. Keep out of reach of children.

PRECAUTIONS

General

For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes.

Information for Patients

Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Data from several studies employing a strain of mice that are 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.

Pregnancy

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.

Nursing Mothers

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.

Pediatric Use

Safety and effectiveness in children 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 these preparations 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

Wash affected areas once or twice daily, or as directed by your physician. Wet face with water. Wet cloth with a little water and work into a full lather. Cleanse face with cloth for 10–20 seconds. Avoid eyes or mucous membranes. Rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing sooner or using less often. Throw away cloth. Do not flush.

HOW SUPPLIED

SIZENDC NUMBER
TRIAZ 3% Foaming Cloths3.2 g. Individual foil-wrapped cloths, 60 per box
NDC 99207-224-60
TRIAZ 6% Foaming Cloths3.2 g. Individual foil-wrapped cloths, 60 per box
NDC 99207-225-60
TRIAZ 9% Foaming Cloths3.2 g. Individual foil-wrapped cloths, 60 per box
NDC 99207-226-60

Store at 15°–25°C (59°–77°F).

U.S. Patent 5,648,389 and Patents Pending

Manufactured for:
Medicis, The Dermatology Company, Scottsdale, AZ 85256
by: Tapemark, West St. Paul, MN 55118
Made in U.S.A.

Prescribing information as of July 2009

www.Triaz.com

15100077

PRINCIPAL DISPLAY PANEL - 60 Cloth Carton (3%)

NDC 99207-224-60

TRIAZ®
(benzoyl peroxide)

3%
Foaming Cloths

60
Cloths

Net wt.
3.2 g each

Principal Display Panel - 60 Cloth Carton (3%)

PRINCIPAL DISPLAY PANEL - 60 Cloth Carton (6%)

NDC 99207-225-60

TRIAZ®
(benzoyl peroxide)

6%
Foaming Cloths

60
Cloths

Net wt.
3.2 g each

Principal Display Panel - 60 Cloth Carton (6%)

PRINCIPAL DISPLAY PANEL - 60 Cloth Carton (9%)

NDC 99207-226-60

TRIAZ®
(benzoyl peroxide)

9%
Foaming Cloths

60
Cloths

Net wt.
3.2 g each

Principal Display Panel - 60 Cloth Carton (9%)

TRIAZ 
benzoyl peroxide   cloth
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)99207-224
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzoyl peroxide (benzoyl peroxide) benzoyl peroxide30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
water 
cetyl alcohol 
sodium lauryl sulfoacetate 
disodium laureth sulfosuccinate 
sodium hydroxide 
glycolic acid 
hypromelloses 
zinc lactate 
sodium pyrrolidone carboxylate 
glycerin 
docusate sodium 
hyaluronate sodium 
silicon dioxide 
dimethicone 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
199207-224-0330 POUCH In 1 CARTONcontains a POUCH
13.2 g In 1 POUCHThis package is contained within the CARTON (99207-224-03)
299207-224-6060 POUCH In 1 CARTONcontains a POUCH (99207-224-01)
299207-224-013.2 g In 1 POUCHThis package is contained within the CARTON (99207-224-60)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER05/27/200903/04/2011

TRIAZ 
benzoyl peroxide   cloth
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)99207-225
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzoyl peroxide (benzoyl peroxide) benzoyl peroxide60 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
water 
cetyl alcohol 
sodium lauryl sulfoacetate 
disodium laureth sulfosuccinate 
sodium hydroxide 
glycolic acid 
hypromelloses 
zinc lactate 
sodium pyrrolidone carboxylate 
glycerin 
docusate sodium 
hyaluronate sodium 
silicon dioxide 
dimethicone 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
199207-225-0330 POUCH In 1 CARTONcontains a POUCH
13.2 g In 1 POUCHThis package is contained within the CARTON (99207-225-03)
299207-225-6060 POUCH In 1 CARTONcontains a POUCH (99207-225-01)
299207-225-013.2 g In 1 POUCHThis package is contained within the CARTON (99207-225-60)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER03/15/200903/04/2011

TRIAZ 
benzoyl peroxide   cloth
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)99207-226
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzoyl peroxide (benzoyl peroxide) benzoyl peroxide90 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
water 
cetyl alcohol 
sodium lauryl sulfoacetate 
disodium laureth sulfosuccinate 
glycolic acid 
sodium hydroxide 
hypromelloses 
zinc lactate 
sodium pyrrolidone carboxylate 
glycerin 
docusate sodium 
hyaluronate sodium 
silicon dioxide 
dimethicone 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
199207-226-0330 POUCH In 1 CARTONcontains a POUCH
13.2 g In 1 POUCHThis package is contained within the CARTON (99207-226-03)
299207-226-6060 POUCH In 1 CARTONcontains a POUCH (99207-226-01)
299207-226-013.2 g In 1 POUCHThis package is contained within the CARTON (99207-226-60)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/01/201003/04/2011

Labeler - Medicis Pharmaceutical Corp. (182837492)
Establishment
NameAddressID/FEIOperations
Tapemark006154595MANUFACTURE
Establishment
NameAddressID/FEIOperations
Contract Pharmaceutical Limited248761249MANUFACTURE
Revised: 03/2011Medicis Pharmaceutical Corp.