Out Back Pain Relief
FDA Label NDC 43979-550

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Elmore Oil Company Pty Ltd for the product Out Back Pain Relief (NDC 43979-550). 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 ingredients, purpose, indication and usage, dosage and administration, warnings, inactive ingredients, keep out of reach of children, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Tea Tree Oil (Melaleuca Alternifolia) - 4.25% (42.5 mg/ml) Eucalyptus Oil (E. Polybractea) - 3.86% (38.6 mg/ml)

Purpose

Massage Oil to assist with relief of joint and muscle pain

Indication And Usage

Temporary relief of joint and muscle pain, including lower back pain

Dosage And Administration

Apply a small amount of Out Back Pain Relief Oil  to the pain affected area and gently massage in until fully absorbed. Use before and after activity for maximum relief.

Warnings

For external use only.
In case of accidental ingestion, get medical help or contact a Poisons Control Center right away.

Inactive Ingredients

Olive Oil (INCI name: Olea Europaea (Olive)

Vanilla (INCI Name: Vanillin)

Keep Out Of Reach Of Children

Keep Out of Reach of Children

Product Label


Sachet (Sachet)

Sachet (Sachet)


Bottle (Bottle)

Bottle (Bottle)

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