Neobenz Micro Plus Pack
Benzoyl Peroxide
Skinmedica Pharmaceuticals, Inc.
Human Prescription Drug
NDC 67402-021Neobenz Micro Plus Pack also known as Benzoyl Peroxide is a human prescription drug labeled by 'Skinmedica Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Neobenz Micro Plus Pack is 67402-021. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Neobenz Micro Plus Pack drug includes . The currest status of Neobenz Micro Plus Pack drug is Active.
Drug Information:
| Drug NDC: | 67402-021 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Neobenz Micro Plus Pack |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Benzoyl Peroxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Skinmedica Pharmaceuticals, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 16 Apr, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 02 Jan, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 02 Jan, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | SkinMedica Pharmaceuticals, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0367402021232
|
| UPC stands for Universal Product Code. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 67402-021-23 | 1 KIT in 1 BOX (67402-021-23) * 7 POUCH in 1 CASE (67402-023-07) / .5 g in 1 POUCH (67402-023-01) * 45 g in 1 TUBE | 16 Apr, 2009 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Neobenz micro plus pack benzoyl peroxide neobenz micro benzoyl peroxide benzoyl peroxide benzoyl peroxide neobenz micro sd benzoyl peroxide benzoyl peroxide benzoyl peroxide
Indications and Usage:
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.
Warnings:
V. warnings when using this product, avoid unnecessary sun exposure and use a sunscreen.
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 : f
Read more...irmly 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.
Adverse Reactions:
Vii . adverse reactions allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.
Use in 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
Clinical Pharmacology:
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.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
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.
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
Information for Patients:
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.
Package Label Principal Display Panel:
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