NeoBenz(R) Micro
SkinMedica Pharmaceuticals, Inc., Carlsbad, CA 92010
FULL PRESCRIBING INFORMATION: CONTENTS*
- I. NEOBENZ(R) MICRO DESCRIPTION
- II. CLINICAL PHARMACOLOGY
- III. NEOBENZ(R) MICRO INDICATIONS AND USAGE
- IV. NEOBENZ(R) MICRO CONTRAINDICATIONS
- V. WARNINGS
- VI. PRECAUTIONS
- VII . NEOBENZ(R) MICRO ADVERSE REACTIONS
- VIII. OVERDOSAGE
- IX. NEOBENZ(R) MICRO DOSAGE AND ADMINISTRATION
- X. HOW SUPPLIED
- REFERENCES
- NeoBenz Micro Wash, Benzoyl Peroxide 7%
FULL PRESCRIBING INFORMATION
NeoBenz® MicroNeoBenz® Micro
NeoBenz® Micro
Rx ONLY.
FOR EXTERNAL USE ONLY.
I. DESCRIPTION
NeoBenz® Micro 3.5% and 5.5% creams, NeoBenz® Micro SD 5.5% single dose cream 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 all cream and SD strengths include: water, glycerin, ethylhexyl palmitate, sorbitol, cetyl alcohol, glyceryl ditaurate, stealryl alcohol, magnesium aluminum silicate, methyl methacrylate/glycol dimethacrylate crosspolymer, silica, citric acid, xanthan gum, methylparaben, sodium citrate, propyIparaben, polyacrylamide, C13-14 isoparaffin, laureth-7, sodium lauryl sulfate. 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:
II. 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.III. INDICATIONS AND USAGE
NeoBenz® Micro, NeoBenz® MicroNeoBenz® MicroIV. CONTRAINDICATIONS
NeoBenz® Micro, NeoBenz® MicroNeoBenz® Microshould not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the products.V. WARNINGS
When using this product, avoid unnecessary sun exposure and use a sunscreen.VI. PRECAUTIONS
(SEE WARNINGS)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 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 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.
VII . ADVERSE REACTIONS
Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.VIII. 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.IX. DOSAGE AND ADMINISTRATION
NeoBenz® Micro, NeoBenz® MicroNeoBenz® Microshould be used once or twice daily on the affected areas. Frequency of use should be adjusted to obtain the desired clinical response. If yo u see medication or white residue on skin after application of NeoBenz® Micro or Micro SD, you are applying too much. Gentle cleansing of the affected areas with a mild cleanser prior to application of NeoBenz® Micro or NeoBenz® MicroNeoBenz® Micro : NeoBenz® Micro
NeoBenz® Micro SD
NeoBenz® Micro WashNeoBenz® Micro
X. HOW SUPPLIED
MicroMicro
Micro
Store between 15o - 25o C (59o - 77o F)
REFERENCES
NeoBenz Micro Wash, Benzoyl Peroxide 7%
NeoBenz(R) Microbenzoyl peroxide, 7% LOTION
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
