Medicines · Natural / Botanical

API Melafix

Active Ingredient
Melaleuca alternifolia extract (1.0% tea tree oil)
Medicine Type
Natural / Botanical
API Melafix

Observe and distinguish

Identification and context

Identity and formulation

API MELAFIX contains 1% cajuput oil according to DailyMed; it is not tea-tree/Melaleuca alternifolia oil. The US label lists uses for wounds and external signs, but DailyMed classifies it as an unapproved drug: label claims are not equivalent to demonstrated clinical efficacy.

Supported indications

The label proposes use for abrasions, wounds and some external signs. A study of fish pathogens found no significant in-vitro antibacterial activity under the tested conditions: it does not replace diagnosis, culture or veterinary treatment for progressive or systemic infection.

Diagnostic prerequisites

Confirm host, diagnosis, net volume, water quality and exact formulation before use. Do not transfer directions between products.

Verify before intervening

Confirmation and decisions

Label directions

For the exact US DailyMed formulation only: 5 mL per 38 L once daily for 7 days, followed by a 25% water change; for new fish, once daily for 3 days. Verify the current local label.

Preparation and monitoring

United States: DailyMed lists cajuput oil 1% and status “unapproved drug other”; the label has not been approved by FDA. Claims, dosage and status are formulation- and jurisdiction-specific.

Species and system compatibility

Not for fish intended for human consumption. Do not generalize tolerance observed in a few species to all fish, invertebrates, corals or life stages; maintain aeration, stop if distress occurs, and seek veterinary care if signs progress.

Interactions and contraindications

Not for fish intended for human consumption. Do not generalize tolerance observed in a few species to all fish, invertebrates, corals or life stages; maintain aeration, stop if distress occurs, and seek veterinary care if signs progress.

Proportionate actions

Management and monitoring

Adverse effects and failure

Not for fish intended for human consumption. Do not generalize tolerance observed in a few species to all fish, invertebrates, corals or life stages; maintain aeration, stop if distress occurs, and seek veterinary care if signs progress.

Operator safety

United States: DailyMed lists cajuput oil 1% and status “unapproved drug other”; the label has not been approved by FDA. Claims, dosage and status are formulation- and jurisdiction-specific.

Regulatory status

Check authorisation, prescription status and conditions of use in the user’s jurisdiction; ornamental and food-producing animals are not interchangeable.

Evidence limitations

Manufacturer directions document only the stated formulation. Efficacy, safety and dosage do not automatically extend to the active substance or other products.

Active ingredient identity

Composition and chemical data

FormulaMixture (terpinen-4-ol, approximately C10H18O)
Molar Mass154.25 g/mol (terpinen-4-ol)

Botanical extract of Melaleuca. Its primary active component is terpinen-4-ol, which provides natural antibacterial properties.

Transparency

Information and documentation

Information

Active Ingredient
Melaleuca alternifolia extract (1.0% tea tree oil)
Medicine Type
Natural / Botanical

Documentation

  • Product Page

    DailyMed — API MELAFIX (cajuput oil 1%)

    REGULATORYHIGH

    Applies only to the stated jurisdiction, product, formulation and revision date.

  • Product Page

    Journal of Exotic Pet Medicine — Safety and efficacy evaluation of Melafix

    PRIMARY RESEARCHMEDIUM

    Study findings apply to the reported taxa, methods and conditions; transfer to other aquaria is an inference.