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ISO 9001:2015 Certified WHO-GMP PCD Pharma Franchise Company in India300+ Products Monopoly Rights Pan India DistributionCall us: +91-86533 91199
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O2-DERM PLUS

Product Packing: 15 GN

Product Composition: Ofloxacin 0.75% + Ornidazole 2% + Itraconazole + Clobetasol propionate 0.05%

Product Price: MRP : 67.5

O2-DERM PLUS

Ofloxacin 0.75% + Ornidazole 2% + Itraconazole + Clobetasol Propionate 0.05% | CREAM 15 GM

O2-DERM PLUS is a topical cream containing Ofloxacin 0.75%, Ornidazole 2%, Itraconazole and Clobetasol Propionate 0.05%. The supplied product brief does not state the strength of Itraconazole, so no Itraconazole concentration has been inferred. This antibacterial + antimicrobial/antiprotozoal + antifungal + potent corticosteroid combination should be used only for specifically diagnosed and approved skin conditions under professional guidance.

Ofloxacin inhibits bacterial DNA gyrase/topoisomerase activity; Ornidazole acts against susceptible anaerobic organisms and protozoa by damaging DNA after intracellular reduction; Itraconazole inhibits fungal ergosterol synthesis; and Clobetasol Propionate is a very potent topical corticosteroid that suppresses inflammation. Steroid-containing antimicrobial combinations should not be used indiscriminately because corticosteroids can mask or worsen infection.

Composition

Each approved measured quantity contains:

·         Ofloxacin - 0.75%

·         Ornidazole - 2%

·         Itraconazole - strength not supplied | Clobetasol Propionate - 0.05%. Exact Itraconazole strength, ingredient specifications, cream base, preservatives and complete excipient details must be verified from the current approved product label.

Dosage form: Topical Cream

Pack size: 15 gm

Uses of O2-DERM PLUS

O2-DERM PLUS may be prescribed only for selected skin conditions where the approved combination of antimicrobial agents and a potent topical corticosteroid is clinically justified.

·         Ofloxacin provides antibacterial activity against susceptible bacteria

·         Itraconazole provides antifungal activity against susceptible fungi; Ornidazole provides activity against susceptible anaerobic organisms/protozoa where clinically relevant

·         Clobetasol Propionate may reduce corticosteroid-responsive inflammation, redness and itching when its use is appropriate

·         The combination is not suitable for every rash, fungal infection, bacterial infection, acne or undiagnosed skin problem

Rapidly spreading infection, fever, severe pain, blistering, pus, facial/eye involvement, extensive skin disease or symptoms that worsen during treatment require prompt professional assessment.

How O2-DERM PLUS Works

O2-DERM PLUS combines antimicrobial actions with a very potent topical corticosteroid:

Ofloxacin: A fluoroquinolone antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV, interfering with DNA replication in susceptible bacteria.

Ornidazole: A nitroimidazole antimicrobial that forms reactive intermediates in susceptible anaerobic organisms/protozoa and damages DNA.

Itraconazole: An azole antifungal that inhibits fungal lanosterol 14-alpha-demethylase, reducing ergosterol synthesis and disrupting fungal cell membranes.

Clobetasol Propionate: A very potent topical corticosteroid that activates glucocorticoid receptors and suppresses inflammatory and immune responses in the skin.

Clinical response and safety depend on correct diagnosis, organism susceptibility, application site and area, skin integrity, duration, occlusion, age and individual patient factors.

 

Dosage and Direction for Use

Apply O2-DERM PLUS only according to the current approved product label and healthcare professional's prescription. Amount, frequency, application area and maximum duration must not be inferred from the composition alone.

Apply a thin layer only to the affected skin area as directed. Wash hands after application unless the hands are being treated. Avoid eyes, mouth, mucous membranes and unintended skin areas.

Do not use under occlusive dressings, on large body areas, or for prolonged periods unless specifically prescribed. Potent corticosteroid absorption and adverse effects can increase with occlusion, large-area use or damaged skin.

Do not stop or extend antimicrobial/steroid treatment on your own. Reassessment is important if symptoms fail to improve, recur quickly or worsen.

Possible Side Effects

Possible adverse effects may include:

·         Local burning, stinging, dryness, itching, redness or irritation

·         Contact dermatitis or hypersensitivity reactions may occur

·         Clobetasol can cause skin thinning, striae, telangiectasia, pigment changes, acneiform eruptions, folliculitis and delayed healing, particularly with prolonged or inappropriate use

·         Prolonged or extensive potent-steroid use can cause systemic corticosteroid effects including hypothalamic-pituitary-adrenal axis suppression, especially in children or under occlusion

·         Inappropriate steroid use can mask, modify or worsen bacterial, fungal or viral skin infection and can promote secondary infection.

Stop use and seek prompt medical advice for severe allergy, rapidly worsening rash/infection, significant skin thinning, visual symptoms after periocular exposure or other serious reactions.

Precautions and Contraindications

Avoid use in patients with known hypersensitivity to Ofloxacin/other quinolones, Ornidazole/other nitroimidazoles, Itraconazole/other azoles, Clobetasol Propionate or any formulation excipient.

·         Do not use on undiagnosed skin disease or untreated viral skin infections, and avoid use where a potent topical corticosteroid is contraindicated according to the approved label.

·         Clobetasol Propionate is a very potent corticosteroid. Avoid prolonged, extensive, facial, groin, axillary or occlusive use unless specifically prescribed and permitted by the label.

·         Use near the eyes requires particular caution; topical corticosteroid exposure around the eye may contribute to glaucoma or cataract risk.

·         Pediatric patients are more susceptible to systemic absorption of potent topical corticosteroids; age restrictions and duration limits must follow the approved label.

·         Pregnancy and breastfeeding require professional assessment. Avoid unnecessary large-area or prolonged exposure, and do not apply to the breast before nursing unless specifically directed.

·         Check the exact Itraconazole strength, approved indications, application sites, maximum duration, cream base/excipients, storage conditions and prescription/regulatory status on the approved label.

·         Keep out of reach of children and use only externally.

·         Drug Interaction Considerations

·         Systemic drug interactions are generally less likely with limited topical use than with oral therapy, but absorption can increase on damaged skin, large areas or with occlusion. Other topical corticosteroids, antimicrobials or irritating skin products should be reviewed before concurrent use.

·         Tell the healthcare professional about other topical medicines and systemic corticosteroids, antibiotics or antifungals being used, especially when treatment is extensive or prolonged.

Business Growth Opportunity with O2-DERM PLUS

O2-DERM PLUS offers pharmaceutical distributors and healthcare entrepreneurs an opportunity to add a 15 gm multi-component topical cream to an appropriately licensed dermatology portfolio.

Promotion must remain strictly consistent with the approved composition, Itraconazole strength, indications, prescription status, duration limits, steroid warnings, antimicrobial stewardship principles and applicable regulations.

Key Business Advantages

·         Ofloxacin 0.75% + Ornidazole 2% + Itraconazole + Clobetasol Propionate 0.05%

·         Multi-component antibacterial, antimicrobial/antiprotozoal, antifungal and potent corticosteroid formulation

·         Convenient topical cream dosage form

·         15 gm pack

·         Suitable addition to an appropriately licensed dermatology portfolio, subject to approved formulation and indications

·         Opportunity for ethical, prescription-focused promotion through appropriate healthcare channels

PCD Pharma Franchise Opportunity for O2-DERM PLUS

Ethics Medinova Private Limited offers PCD Pharma Franchise opportunities for O2-DERM PLUS in selected territories across India, subject to availability, applicable regulations and mutually agreed business terms.

Franchise partners may benefit from the company's product portfolio, promotional support, supply coordination and business assistance.

 

Franchise Support May Include

·         Monopoly-based territory opportunities, subject to availability

·         Promotional materials and visual aids consistent with approved claims

·         Product information and marketing support

·         Reliable supply coordination

·         Access to a growing pharmaceutical product portfolio

·         Professional partner assistance

Partner with Ethics Medinova to explore PCD Pharma Franchise opportunities for O2-DERM PLUS and other quality-focused healthcare products.

Third-Party Manufacturing Support for Topical Creams

Ethics Medinova also supports eligible businesses exploring third-party manufacturing of formulations similar to O2-DERM PLUS under their own brand, subject to applicable drug licensing, regulatory and manufacturing requirements.

Our third-party manufacturing support may include:

·         Approved formulation and 15 gm pack configuration support, subject to regulatory feasibility

·         Private-label manufacturing opportunities

·         Customized packaging and branding support

·         Product label and pack configuration assistance

·         Manufacturing coordination through suitable licensed facilities

·         Support for documentation and applicable regulatory requirements

This service may be suitable for eligible pharmaceutical companies seeking to expand an appropriately licensed dermatology portfolio.

Frequently Asked Questions About O2-DERM PLUS

1. What is O2-DERM PLUS?

O2-DERM PLUS is a 15 gm topical cream containing Ofloxacin 0.75%, Ornidazole 2%, Itraconazole and Clobetasol Propionate 0.05% according to the supplied product brief. The Itraconazole strength was not supplied.

2. What is the role of Ofloxacin?

Ofloxacin is a fluoroquinolone antibacterial that inhibits bacterial DNA gyrase/topoisomerase activity and acts against susceptible bacteria.

3. What is the role of Itraconazole?

Itraconazole is an azole antifungal that inhibits ergosterol synthesis in susceptible fungi. Its exact concentration in O2-DERM PLUS must be verified from the approved label.

4. Why does the formulation contain Clobetasol Propionate?

Clobetasol is a very potent topical corticosteroid used to suppress inflammation in appropriately selected steroid-responsive conditions. It can mask or worsen infection if used inappropriately.

5. Can O2-DERM PLUS be used for any skin rash?

No. The combination should be used only for a properly diagnosed and approved condition where all components are clinically justified. Indiscriminate use can worsen or mask infection and cause steroid-related adverse effects.

6. How should O2-DERM PLUS be used?

Apply only in the amount, frequency, area and duration stated on the approved label or prescribed by a healthcare professional. Avoid prolonged, extensive or occlusive use unless specifically directed.

7. Is a PCD Pharma Franchise available for O2-DERM PLUS?

Yes. Ethics Medinova offers PCD Pharma Franchise opportunities for selected products and territories, subject to availability, applicable regulations and mutually agreed terms.

8. Can this formulation be manufactured under my own brand?

Eligible businesses interested in a similar topical cream may explore third-party manufacturing and private-label support with Ethics Medinova, subject to verified ingredient strengths, applicable licensing, manufacturing and regulatory requirements.

Disclaimer

O2-DERM PLUS product information in this document is for general professional and business information. The supplied product brief states Ofloxacin 0.75% + Ornidazole 2% + Itraconazole + Clobetasol Propionate 0.05%, CREAM 15 GM. The strength of Itraconazole was not supplied and has not been inferred. Exact Itraconazole strength, ingredient specifications, approved indications, application amount/frequency, treatment duration, age restrictions, contraindications, warnings, interactions, prescription/regulatory status, cream base/excipients, manufacturing specifications and storage instructions must be verified against the current approved product label before manufacture, promotion, recommending, dispensing or use. Clobetasol Propionate is a very potent topical corticosteroid and inappropriate use can mask/worsen infection and cause local or systemic corticosteroid adverse effects. This document is not a substitute for professional medical advice.

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