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Name:Neobenz Micro Sd
Manufacturer:Intendis Inc.
Category:Prescription Marketed Drugs


NeoBenz® Micro SD (benzoyl peroxide cream 5.5%) Pre-filled Sponge ApplicatorNeoBenz® Micro Wash (benzoyl peroxide 7%)Rx ONLYFOR EXTERNAL USE ONLY

NEOBENZ MICRO SD - benzoyl peroxide cream 
NEOBENZ MICRO WASH PLUS PACK - benzoyl peroxide   
NEOBENZ MICRO WASH - benzoyl peroxide solution 
Intendis Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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NeoBenz® Micro SD (benzoyl peroxide cream 5.5%)
Pre-filled Sponge Applicator
NeoBenz® Micro Wash (benzoyl peroxide 7%)
Rx ONLY
FOR EXTERNAL USE ONLY

DESCRIPTION

NeoBenz®Micro SD 5.5% single dose cream pre-filled sponge applicator and NeoBenz®Micro Wash 7% are topical preparations containing benzoyl peroxide as the active ingredient incorporated into patented porous microspheres (MICROSPONGE®* delivery system) composed of methyl methacrylate/glycol dimethacrylate crosspolymer. This polymeric system has been shown to provide gradual release of active ingredient into the skin1 and absorb natural skin oils2.

Ingredients for the SD include C13-14 isoparaffin, cetyl alcohol, citric acid, ethylhexyl palmitate, glycerin, glyceryl dilaurate, laureth-7, magnesium aluminum silicate, methyl methacrylate/glycol dimethacrylate crosspolymer, methylparaben, polyacrylamide, propylparaben, silica, sodium citrate, sodium lauryl sulfate, sorbitol, stearyl alcohol, water, and xanthan gum.

Ingredients for the Wash include citric acid, cocamidopropyl betaine, cocamine oxide, disodium laureth sulfosuccinate, edetate disodium, fragrance, glycerin, hydrogenated castor oil, hypromellose, magnesium aluminum silicate, methyl methacrylate/glycol dimethacrylate crosspolymer, methylparaben, PEG-150 pentaerythrityl tetrastearate (and) PEG-6 caprylic/capric glycerides, PEG-40 hydrogenated castor oil, poloxamer 182, purified water, and xanthan gum.

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:

Chemical 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

NeoBenz®Micro SD and NeoBenz®Micro Wash are indicated for use in the topical treatment of mild to moderate acne vulgaris.

CONTRAINDICATIONS

NeoBenz®Micro SD and NeoBenz®Micro Wash should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the products.

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. Avoid contact with eyes and mucous membranes. If severe irritation develops, discontinue use and institute appropriate therapy.

Information for Patients

Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. Avoid contact with hair, fabrics or carpeting as benzoyl peroxide will cause bleaching or discoloration. If excessive 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 this finding 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 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 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

NeoBenz®Micro SD and NeoBenz®Micro Wash should be used once or twice daily on the affected areas. Frequency of use should be adjusted to obtain the desired clinical response. if you see medication or white residue on skin after application of NeoBenz®Micro SD, you are applying too much. Gentle cleansing of the affected areas with a mild cleanser prior to application of NeoBenz®Micro SD may be beneficial. Clinically visible improvement will normally occur by the third week of therapy. Maximum lesion reduction may be expected after approximately eight to twelve weeks of drug use. Continuing use of the drug is normally required to maintain a satisfactory clinical response.

NeoBenz®Micro SD: Firmly squeeze applicator until seal between applicator and sponge has broken. Apply medication by rubbing sponge in small circular motions on affected areas. Dispose of each applicator after single use only.

NeoBenz®Micro Wash: Shake well before using. Wet skin areas to be treated: apply NeoBenz Micro Wash by massaging gently into skin for 10-20 second, working into a full lather. Rinse thoroughly and pat dry.

HOW SUPPLIED

NeoBenz®Micro SD is supplied as follow:

SIZE: 1 box of thirty 0.5 gram applicators

NDC NUMBER: 10922-821-30

(benzoyl peroxide cream 5.5%) Pre-filled Sponge Applicator

NeoBenz®Micro Wash Plus Pack

NDC NUMBER: 10922-822-23

Contains:

1 tottle (180 gram), NeoBenz®Micro Wash (benzoyl peroxide 7%)

1 convenient travel case containing seven 0.5 gram applicators, NeoBenz®Micro SD (benzoyl peroxide cream 5.5%) Pre-filled Sponge Applicator

Store between 15° - 25°C (59° - 77°F).

REFERENCES

1. Wester RC, Patel R, Nacht S, Leyden J, Melendres J, Maibach H. Controlled release of benzoyl peroxide from a porous microsphere polymeric system can reduce topical irritancy. J. Am. Acad.Dermatol. 1991; 24: 720-726.

2. Meyer R. Rosen (ed.), Delivery System Handbook for Personal Care and Cosmetic Products, 332-352 (2005).

Covered by US Patents: 5,879,716; 6,007,264.

*MICROSPONGE ® is a registered trademark of AMCOL Health and Beauty Solutions, Inc, a subsidiary of AMCOL International Corporation.

www.neobenz.com

© 2010, Intendis, Inc. All rights reserved. August 2010

Made in USA

Distributed by:

INTENDIS, Inc.
Morristown, NJ 07962

Intendis is part of the Bayer Group

6707302

The following are representative examples of NeoBenz labeling. See the "How Supplied" section for a complete listing of all components

NeoBenz®Micro Trade Carton

NDC 10922-821-30

NeoBenz®Micro SD

(benzoyl peroxide cream 5.5%)

Intendis

For External Use Only

KEEP OUT OF REACH OF CHILDREN

Rx Only

Contains thirty 0.5 gram pre-filled sponge applicators plus a convenient travel case

www.neobenz.com

Trade Carton 1

Trade Carton 2

NeoBenz Micro Wash Tube

NDC 10922-824-01
Rx Only

NeoBenz®Micro Wash

(benzoyl peroxide 7%)

INTENDIS

www.neobenz.com

Net Wt 6.35 oz (180 g)

microwash


NEOBENZ MICRO SD 
benzoyl peroxide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10922-821
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 55 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL  
CITRIC ACID MONOHYDRATE  
ETHYLHEXYL PALMITATE  
GLYCERIN  
MAGNESIUM ALUMINUM SILICATE  
METHYLPARABEN  
PROPYLPARABEN  
SODIUM LAURYL SULFATE  
SORBITOL  
STEARYL ALCOHOL  
WATER  
XANTHAN GUM  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10922-821-30 30 APPLICATOR ( APPLICATOR) in 1 BOX contains a APPLICATOR
1 0.5 g in 1 APPLICATOR This package is contained within the BOX (10922-821-30)
2 NDC:10922-821-71 15 APPLICATOR ( APPLICATOR) in 1 BOX contains a APPLICATOR
2 0.5 g in 1 APPLICATOR This package is contained within the BOX (10922-821-71)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 10/22/2010

NEOBENZ MICRO WASH PLUS PACK 
benzoyl peroxide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10922-822
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10922-822-23 1 KIT ( KIT) in 1 CASE None
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE   180 g
Part 2 7 APPLICATOR   3.5 g
Part 1 of 2
NEOBENZ MICRO WASH 
benzoyl peroxide solution
Product Information
Item Code (Source) NDC:10922-824
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 70 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
COCAMIDOPROPYL BETAINE  
DISODIUM LAURETH SULFOSUCCINATE  
EDETATE DISODIUM  
GLYCERIN  
HYDROGENATED CASTOR OIL  
HYPROMELLOSES  
MAGNESIUM ALUMINUM SILICATE  
METHYLPARABEN  
POLYOXYL 40 HYDROGENATED CASTOR OIL  
POLOXAMER 182  
WATER  
XANTHAN GUM  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 10922-824-01 180 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 10/22/2010

Part 2 of 2
NEOBENZ MICRO SD 
benzoyl peroxide cream
Product Information
Item Code (Source) NDC:10922-821
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 55 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL  
CITRIC ACID MONOHYDRATE  
ETHYLHEXYL PALMITATE  
GLYCERIN  
MAGNESIUM ALUMINUM SILICATE  
METHYLPARABEN  
PROPYLPARABEN  
SODIUM LAURYL SULFATE  
SORBITOL  
STEARYL ALCOHOL  
WATER  
XANTHAN GUM  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 10922-821-07 7 APPLICATOR ( APPLICATOR) in 1 CASE contains a APPLICATOR
1 .5 g in 1 APPLICATOR This package is contained within the CASE (10922-821-07)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other


Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 10/22/2010

NEOBENZ MICRO WASH 
benzoyl peroxide solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10922-818
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 70 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
COCAMIDOPROPYL BETAINE  
DISODIUM LAURETH SULFOSUCCINATE  
EDETATE SODIUM  
GLYCERIN  
HYDROGENATED CASTOR OIL  
HYPROMELLOSES  
MAGNESIUM ALUMINUM SILICATE  
METHYLPARABEN  
POLYOXYL 40 HYDROGENATED CASTOR OIL  
POLOXAMER 182  
WATER  
XANTHAN GUM  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10922-818-71 12 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 5 g in 1 TUBE This package is contained within the CARTON (10922-818-71)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 10/22/2010

Labeler - Intendis Inc. (363706040)
Establishment
Name Address ID/FEI Operations
DPT Laboratories, Ltd. 832224526 MANUFACTURE, PACK
Establishment
Name Address ID/FEI Operations
Catalent Pharma Solutions, LLC 806746405 PACK

Revised: 10/2010 Intendis Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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