Layers 01–02 · Evidence boundary
What this public record establishes — and what remains held.
Layer 01 · Controlled catalogue facts
- Generic identity: Ofloxacin.
- Dosage form: eye drops.
- Catalogue strength / concentration: 0.3%.
- Catalogue pack: Dropper bottle 5 mL.
- Catalogue category: Anti-Infectives.
Layer 02 · Unresolved product-specific fields
- Definitive intended route/presentation: ophthalmic, otic, or separate route-specific products.
- Sterility, preservative/excipient system, pH/osmolality and container-closure specification for the exact route.
- Approved indication, age eligibility, administration and after-opening/in-use instructions.
- Registration, route-specific artwork, shelf life, manufacturing route and supply status.
External ophthalmic and otic labels are separate route-specific products even at the same 0.3% concentration. They do not resolve which route LP-040 is intended to support.
02 · Variants
Preserve each catalogue row without inferring missing SKU relationships.
| Variant | Proposed strength / concentration | Dosage form | Presentation detail | Pack relationship | Evidence status |
|---|---|---|---|---|---|
| A | 0.3% | Eye drops | — | Dropper bottle 5 mL | Do not infer otic authorisation or eye/ear interchangeability from the conflicting source fields. |
The table reproduces or structures catalogue-level fields. It does not create an approved SKU, instruction or specification where the source record does not provide one.
03 · External reference context
Ingredient and dosage-form background
Ofloxacin is a fluoroquinolone antibiotic. This catalogue record is treated as an ophthalmic eye-drop presentation because that is the stated dosage form; eye and ear products must not be assumed interchangeable. The original combined route wording does not authorize both uses. This educational profile addresses the eye route and does not establish the approved indications, formulation specifications or marketing status of a Luang Pharma product.
Clinical context and therapeutic role
A suspected bacterial eye infection needs assessment of the site, symptoms and possible need for ophthalmic examination. Corneal involvement, pain, reduced vision, light sensitivity or symptoms in a contact-lens wearer require prompt evaluation. The choice of an ophthalmic antibiotic depends on the diagnosis and local guidance. A bottle labeled for the ear should never be substituted into the eye, and a catalogue heading cannot resolve route-specific authorization.
Selected safety context
Local stinging, burning, itching or temporary blurred vision may occur. A serious hypersensitivity reaction is possible. Contamination of the applicator or sharing eye-drop bottles can spread infection. Increasing pain, worsening vision or failure to improve needs medical review. Follow professional advice regarding contact lenses. Only a verified ophthalmic product should be applied to the eye; preservative content, in-use period and other formulation-specific precautions must come from the actual product information.
Selected external context only. It is not a complete risk profile or Luang Pharma approved labelling. The exact authorised IFU/label and applicable professional guidance control product use.
Formulation, presentation and handling evidence
The catalogue identifies an ophthalmic liquid presentation. Ophthalmic suitability, sterility, preservative content, container design and the approved route must be confirmed for the actual product. A percentage strength alone does not establish interchangeability with ear drops, skin solutions or another eye-drop formulation.
Follow hand-hygiene and applicator instructions, avoiding contact between the dropper tip and the eye or other surfaces. Keep the bottle labeled and do not share it. The in-use period, storage conditions and handling after opening are specific to the supplied product.
Final instructions, storage conditions, shelf life and any after-opening/in-use limits require the exact controlled product documentation; none is created from a comparator reference.
Points for professional review
A qualified prescriber should establish the infection and need for treatment, consult current local guidance and resistance information where relevant, and select a suitable route. Generic reference literature is not a substitute for the authorized local product information.
Layer 04 · Documentation gate
Controlled product documents must close the held fields.
Before this medicine record can support product-specific clinical, technical or supply claims, the exact finished-product documentation must resolve the held fields.
Route-specific finished-product formula/specification and sterility/container evidence.
Controlled label/leaflet establishing the intended route and indications.
Route-specific packaging artwork and container/closure specification.
Registration/market-status and manufacturing evidence for the exact route-specific presentation.
Editorial source check: archived record dated 2026-09-11.
Qualified product/medical review: Not recorded at B07c checkpoint
Approved Luang Pharma label: Not provided or established
Registration / availability / supply: not established by this public record.
Layer 03 · Sources & review
External references are attributed, not adopted as Luang Pharma labelling.
| Source | Recorded revision / check | How it is used |
|---|---|---|
| DailyMed: Ofloxacin ophthalmic solution 0.3%Archived source classification: US official ophthalmic label example | Source revision recorded: Label updated 19 January 2026; Archived access check: 2026-09-11 | External reference; not Luang Pharma labelling, product approval, registration, equivalence, manufacturing evidence or supply evidence. |
| DailyMed: Ofloxacin otic solution 0.3%Archived source classification: US official otic label example | Source revision recorded: Label updated 13 August 2026; Archived access check: 2026-09-11 | External reference; not Luang Pharma labelling, product approval, registration, equivalence, manufacturing evidence or supply evidence. |
External sources may describe authorised products, public-health guidance or device classes. They do not establish equivalence, approval, model performance, manufacturing status or supply eligibility for LP-040.