NeoBenz Micro Plus Pack
benzoyl peroxide · Kit
Uses
III. INDICATIONS AND USAGE NeoBenz® Micro, NeoBenz® Micro SD and NeoBenz® Micro Wash are indicated for use in the topical treatment of mild to moderated acne vulgaris.
Dosage and administration
IX. DOSAGE AND ADMINISTRATION NeoBenz® Micro, 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 yo u see medication or white residue on skin after application of NeoBenz® Micro or NeoBenz® 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® Micro SD may be beneficial. Clinically visible improvement will normally occur by the third week if therapy. Maximum lesion reduction may be expected after approximately eight to twelve weeks for drug use. Continuing use of the drug us normally required to maintain a satisfactory clinical response. NeoBenz® Micro : If applying to the entire face, apply a pea-sized amount of NeoBenz® Micro to one fingertip and dab onto cheeks, forehead and chin. Spread evenly onto entire face. NeoBenz® Micro S D : Firmly squeeze applicator until seal between applicator and sponge has broken. Apply medication by rubbing sponge on 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 seconds, working into a full lather. Rinse thoroughly and pat dry.
Contraindications
IV. CONTRAINDICATIONS NeoBenz® Micro, 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
V. WARNINGS When using this product, avoid unnecessary sun exposure and use a sunscreen.
Precautions
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.
Side effects
VII . ADVERSE REACTIONS Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.
Pregnancy
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.
Pediatric use
Pediatric Use: Safety and effectiveness in children below the age of 12 have not been established.
Overdosage
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.
Description
I. DESCRIPTION NeoBenz® Micro 5.5% cream, 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 skin 1 and absorb natural skin oils 2 . Ingredients for the cream and SD 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 (C 14 H 10 O 4 ) is represented by the following structure: Benzoyl-Peroxide-Structural-Formula
How supplied
X. HOW SUPPLIED NeoBenz® Micro SD is supplied as follows: SIZE: 1 box of thirty 0.5 gram applicators NDC NUMBER: 67402-023-30 (benzoyl peroxide cream 5.5%) Pre-filled Sponge Applicator NeoBenz® Micro Wash Plus Pack NDC NUMBER: 67402-029-23 Contains: 1 tottle (180 gram), NeoBenz® Micro Wash (benzoyl peroxide 7%) 1 box of seven 0.5 gram applicators, NeoBenz® Micro SD (benzoyl peroxide cream 5.5%) Pre-filled Sponge Applicator NeoBenz® Micro Cream Plus Pack NDC NUMBER: 67402-021-23 Contains: 1 tube (45 gram), NeoBenz® Micro (benzoyl peroxide cream 5.5%) 1 box of seven 0.5 gram applicators, NeoBenz® Micro SD (benzoyl peroxide cream 5.5%) Pre-filled Sponge Applicator
Storage
Store between 15 o - 25 o C (59 o - 77 o F)
Patient information
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.
Label text from the FDA structured product label by SkinMedica Pharmaceuticals, Inc. (revised May 12, 2010). Long sections are shortened; the complete label is on DailyMed.
NeoBenz Micro Plus Pack NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 67402-021 | Kit | SkinMedica Pharmaceuticals, Inc. | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is NeoBenz Micro Plus Pack used for?
III. INDICATIONS AND USAGE NeoBenz® Micro, NeoBenz® Micro SD and NeoBenz® Micro Wash are indicated for use in the topical treatment of mild to moderated acne vulgaris.
What are the side effects of NeoBenz Micro Plus Pack?
VII . ADVERSE REACTIONS Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy. See the full label for the complete list.
Who makes NeoBenz Micro Plus Pack?
NeoBenz Micro Plus Pack is listed by 1 labeler in the FDA NDC directory, including SkinMedica Pharmaceuticals, Inc..