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| Product NDC Code | 67402-021 | ||||
|---|---|---|---|---|---|
| Drug Name | Neobenz micro plus pack |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| Labeler Name | SkinMedica Pharmaceuticals, Inc. | ||||
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Overdosage of NeoBenz Micro Plus Pack
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.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.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.VII . ADVERSE REACTIONS Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.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.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.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.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.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
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Spl product data elements
Usually a list of ingredients in a drug product.NeoBenz Micro Plus Pack benzoyl peroxide NeoBenz Micro benzoyl peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE NeoBenz Micro SD benzoyl peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.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.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package Label. Principal Display Panel. NDC 67402-021-23 NeoBenz Micro Cream Plus Pack NeoBenz Micro (benzoyl peroxide Cream 5.5%) Net Wt. 45 g Tube NeoBenz Micro SD (benzoyl peroxide cream 5.5%) Pre-Filled Sponge Applicator Contains seven 0.5g applicators in a convenient travel case Rx Only Combination Package - Do Not Break Up NBM-Cream-PlusPack-carton-01 NBM-5.5-45-01 NBM-SD-case-01
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.NeoBenz ® Micro (benzoyl peroxide cream 5.5%) NeoBenz ® Micro SD (benzoyl peroxide cream 5.5%) Pre-filled Sponge Applicator NeoBenz ® Micro Wash (benzoyl peroxide 7%) Rx ONLY. FOR EXTERNAL USE ONLY.
Distributed by SkinMedica Pharmaceuticals, Inc., Carlsbad. CA 92010 Covered by Us Patents: 4,690,825; 5,145,675; 5,879,716; 6,007,364. *MICROSPONGE® is a registered trademark of AMCOL Health and Beauty Solutions, Inc, a subsidiary of AMCOL International Corporation. 129044 April 2009 P7001-05
NeoBenz Micro Plus Pack: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.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.
References
This field may contain references when prescription drug labeling must summarize or otherwise relay on a recommendation by an authoritative scientific body, or on a standardized methodology, scale, or technique, because the information is important to prescribing decisions.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).
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.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
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use: Safety and effectiveness in children below the age of 12 have not been established.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.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 and handling
Information about safe storage and handling of the drug product.Store between 15 o - 25 o C (59 o - 77 o F)
Precautions
Information about any special care to be exercised for safe and effective use of the drug.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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.V. WARNINGS When using this product, avoid unnecessary sun exposure and use a sunscreen.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API