Spotex
Erythromycin
Pella Pharmaceuticals Co. Ltd
Human Prescription Drug
NDC 82160-126Spotex also known as Erythromycin is a human prescription drug labeled by 'Pella Pharmaceuticals Co. Ltd'. National Drug Code (NDC) number for Spotex is 82160-126. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Spotex drug includes Erythromycin - 1200 mg/30g . The currest status of Spotex drug is Active.
Drug Information:
| Drug NDC: | 82160-126 |
| 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: | Spotex |
| 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: | Erythromycin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Pella Pharmaceuticals Co. Ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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: | ERYTHROMYCIN - 1200 mg/30g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | 10 Sep, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 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: | 31 Dec, 2024 |
| 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: | Pella Pharmaceuticals Co. Ltd
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 250697
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000009982
N0000175877
N0000175935
M0028311
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 63937KV33D
|
| 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. |
| Pharmacologic Class EPC: | Macrolide [EPC]
Macrolide Antimicrobial [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Decreased Sebaceous Gland Activity [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class CS: | Macrolides [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Decreased Sebaceous Gland Activity [PE]
Macrolide Antimicrobial [EPC]
Macrolide [EPC]
Macrolides [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 82160-126-01 | 1 TUBE in 1 CARTON (82160-126-01) / 30 g in 1 TUBE | 10 Sep, 2013 | 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:
Spotex erythromycin erythromycin erythromycin
Drug Interactions:
Drug interactions do not use spotex with any other acne products that are used on the skin unless your doctor or pharmacist has told you that you can. while you are using spotex , do not use skin cleansers that remove dead skin (these are called exfoliants), medicated soaps or cosmetics containing alcohol. these could make your skin irritated or dry. please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Indications and Usage:
Indications spotex is indicated for the treatment of acne vulgaris, acne appears as blackheads and whiteheads which people often refer to as pimples or spots. spotex attacks the bacteria that are one of the main causes of acne. the name of these bacteria is propionibacterium acnes
Warnings:
Warnings topical gels and creams are intended for external use only and should be kept away from eyes, nose, mouth, and other mucous membranes because of its irritant effect. do not apply to eyelids or to the skin at the corners of the eyes and mouth. avoid the angles of the nose and nasolabial fold (if treatment in these areas; is necessary, apply very sparingly). topical use may induce severe local erythema and peeling at the site of application. if the degree of local irritation warrants, patients should be directed to use the medication less frequently, discontinue use temporarily or discontinue use altogether.
General Precautions:
This is a medicament medicament is a product which affects your health and its consumption contrary to instructions is dangerous for you. strictly follow the doctor's prescription, the method of use and the instruction of the pharmacist who sold the medicament. the doctor and the pharmacist are experts in medicine, its benefits and risks. do not by yourself interrupt the period of treatment prescribed for you. do not repeat the same prescription without consulting your doctor. keep medicament out of reach of children
Dosage and Administration:
Dosage and administration use spotex once in the morning and once in the evening, unless your doctor or pharmacist has told you otherwise. wash the affected areas with water or with a mild cleanser, and then thoroughly dry the affected areas and gently apply on a thin film of spotex using the tips of your fingers. don't forget to wash your hands afterwards. the alcohol quickly evaporates and erythrornycin penetrates into your skin without leaving an unpleasant film, after you have used spotex ; screw the cap tightly on the tube. how long you will have to use spotex will depend on how quickly your acne improves. you may well use spotex gel for one month and then a lower strength product for one more month. your doctor will decide which strength to prescribe for you. it is recommended to use sunscreens over treated areas before sun exposure.
Contraindications:
Contraindications spotex is contraindicated if you are allergic (hypersensitive) to erythromycin or any of the other ingredients of spotex . an allergic reaction may include a rash or itching.
Adverse Reactions:
Side effects like all medicines spotex can cause side effects, although not everybody gets them. these might include dryness, itching, redness, peeling or oiliness. you might feel a stinging or burning sensation when you put it on your skin. usually the effects are not serious and happen at the start of treatment. more often than not, they go away as you continue to use the gel. if any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Drug Interactions:
Drug interactions do not use spotex with any other acne products that are used on the skin unless your doctor or pharmacist has told you that you can. while you are using spotex , do not use skin cleansers that remove dead skin (these are called exfoliants), medicated soaps or cosmetics containing alcohol. these could make your skin irritated or dry. please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Use in Pregnancy:
Pregnancy ask your doctor or pharmacist for advice before taking any medicine.
Overdosage:
Overdosage do not put too much spotex on your skin. you will not get rid of the acne any quicker. if you put on too much, your skin may become irritated and red. some peeling or discomfort could also occur. if any of these happen, use spotex once a day in the evening until they have gone. then apply spotex twice a day as you did previously. if the effects continue or are causing you a lot of discomfort, stop using the product and ask your doctor or pharmacist for advice. in the rare event that you accidentally swallow any of this product, seek medical advice.
Description:
Properties erythromycin which belongs to a class of chemicals called macrolide antibiotics; exerts its antibacterial action by binding to the 50s ribosomal subunit of susceptible bacteria and suppressing protein synthesis. erythromycin is usually bacteriostatic but may be bactericidal in high concentrations or against highly susceptible organisms.
How Supplied:
How supplied 30 g packs.
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