benzoyl peroxide
Dosage Form: cream, solution
NeoBenz® Micro SD (benzoyl peroxide cream 5.5%)
Pre-filled Sponge Applicator
NeoBenz® Micro Wash (benzoyl peroxide 7%)
Rx ONLY
FOR EXTERNAL USE ONLY
Neobenz Micro SD 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:
Neobenz Micro SD - 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 for Neobenz Micro SD
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.
Neobenz Micro SD 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 is Neobenz Micro SD 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
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)
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| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 10/22/2010 | ||
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| 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 | ||||||||||||||||||||||||||||||
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| 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 | |
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