Tea Tree Antiseptic
FDA Label NDC 51257-642

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 51257-642). 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 active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Melaleuca Alternifolia (Tea Tree) Leaf Oil 5%

Purpose

First Aid Antiseptic

Uses

First aid to help protect against infection in minor cuts, scrapes and burns.

Warnings

For external use only

Do Not Use

  • in the eyes or apply over large areas of the body
  • longer than 1 week unless directed by a doctor.

Ask A Doctor Before Use If You Have

deep or puncture wounds, animal bites, or serious burns.

Stop Use And Ask A Doctor If

condition persists or worsens.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Other Safety Information

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Other Information

  • store below 86 F.

Inactive Ingredients

Paraffin white soft, Mineral oil, Cetostearyl alcohol, dl-alpha tocopheryl acetate

Description

DISTRIBUTED BY: Integria Healthcare (US) Inc., Paramount CA 90723-3426.

USA Health Food: Natural Organics Inc, 548 Broadhollow Road Melville NY 11747

MADE IN AUSTRALIA

Principal Display Panel

NDC 51257-642-02

Thursday Plantation

Australia's Original

TEA TREE ANTISEPTIC OINTMENT

First aid to help protect

against infection in minor

cuts, scrapes and burns

Net Wt 1.76 oz (50 g)




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