Tea Tree Antiseptic
FDA Label NDC 51257-644

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Integria Healthcare Us Inc. for the product Tea Tree Antiseptic (NDC 51257-644). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Melaleuca Alternifolia (Tea Tree) Leaf Oil 5%

Otc - Purpose

Antiseptic

Indications & Usage

protects cuts, abrasions, cracked dry skin, chapped lips and other minor wounds against infection

Warnings

For external use only

Otc - Ask Doctor

In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Otc - Stop Use

Stop use and ask a doctor if redness, irritation or pain persists or increases, or if infection occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children, if swallowed get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • clean the affected area
  • apply small amount two or three times a day
  • may be covered with a sterile bandage

Storage And Handling

store below 86 degrees F

Inactive Ingredient

Beeswax, Canola Oil, Copernicia Cerifera (Carnauba) Wax, Macadamia Integrifolia Seed Oil, Tocopherol

Package Label.Principal Display Panel

Tea Tree Antiseptic Ointment Label (50gjarlabel)

Tea Tree Antiseptic Ointment Label (50gjarlabel)

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