Spotex

Manufacturer
Pella Pharmaceuticals Co. Ltd
Effective date
2024-12-31
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
130
Source
full-release
Hydrated at
2026-05-31 21:21:18

Label at a glance#

ProductSpotex
Active ingredientERYTHROMYCIN
Label structure15 sections

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 ...

Storage and handling

Store below 25 °C.

Label contents#

Full prescribing information#

Composition

COMPONENTS

Each 1 g contains: Erythromycin base 40 mg.
Excipients: Ethanol 99.9%, Hydroxypropyl cellulose, Butylated hydroxytoluene.

Properties

DESCRIPTION SECTION

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.

Indications

INDICATIONS & USAGE SECTION

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

Contraindications

CONTRAINDICATIONS SECTION

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.

Precautions

PRECAUTIONS SECTION

If you use Spotex on your face don t get it in your eyes, nose/nostrils, mouth, or on your lips. If you do, wash the area with large amount of warm water. And do not use Spotex on areas where you have cuts or scrapes.
Excessive exposure to sunlight or ultraviolet rays ( sun lamps) should be avoided during treatment with Spotex because the additional irradiation may lead to a more intense action.
If sunburn occurs, it is advisable to interrupt therapy until the severe erythema and peeling subside. Patients whose occupations require considerable exposure to the sun should exercise particular caution.

Pregnancy

PREGNANCY SECTION

Ask your doctor or pharmacist for advice before taking any medicine.

Lactation

LACTATION SECTION

Do not apply Spotex on your chest if you are breast feeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Drug Interactions

DRUG INTERACTIONS SECTION

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.

Warnings

WARNINGS SECTION

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.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

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.

Overdosage

OVERDOSAGE SECTION

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.

Side Effects

ADVERSE REACTIONS SECTION

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.

Storage

STORAGE AND HANDLING SECTION

Store below 25 °C.

How supplied

HOW SUPPLIED SECTION

30 g packs.

THIS IS A MEDICAMENT

GENERAL PRECAUTIONS SECTION

  • 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

Primary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary PackagePrimary Package

Secondary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Secondary PackageSecondary Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
250697erythromycin 4 % Topical GelPSN130
250697erythromycin 0.04 MG/MG Topical GelSCD130
250697erythromycin 4 % Topical GelSY130

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ERYTHROMYCIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d329c2e1-5ae8-4e64-aea0-77ecea3fa1abProduct name320250717
3b331500-3b74-bd2b-fede-d46839f2f4d5Product name620240313
fdae2630-eae0-4769-abfd-8f33d5b771b4Product name320240202
8c898317-b543-1e4e-254f-84cec2f3f57eProduct name220191002
64ae94c0-3212-d73a-92da-9e6dd85c6ebeProduct name220180118
edcfa1cf-915f-1a4c-d0aa-508cc66e70d9Product name220170816
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
57850177-5927-151f-e1fa-7e2ca47f81e5Product name120140508
8ee71591-1d8f-e24e-242b-bfef131e3168Product name120140508
bff5cf99-0f45-fa15-2a76-b160c3c4cc3cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82160-126-01Spotex30 g in 1 TUBEGEL30130
82160-126-01Spotex1 in 1 CARTONGEL1130

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82160-126SPOTEX (ERYTHROMYCIN) GEL [PELLA PHARMACEUTICALS CO. LTD]130Legacy NDC, 2 package rows20250101_d0485ea3-984d-3193-e053-2995a90a078f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82160-12682160-126-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
ERYTHROMYCIN63937KV33DACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2a91378f-edcc-7b98-e063-6394a90aba35d0485ea3-984d-3193-e053-2995a90a078f2024-12-31Warnings, Adverse reactionsExact identifier
spl id: 2a91378f-edcc-7b98-e063-6394a90aba35
spl set id: d0485ea3-984d-3193-e053-2995a90a078f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.