Pain Release Oil
FDA Label NDC 69204-008

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natures Formulae Health Products Ltd. for the product Pain Release (NDC 69204-008). 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 drug facts active ingredient, otc - purpose, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts Active Ingredient

Menthol 1.37%

Otc - Purpose

Purpose Topical Analgesic

Uses For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, brusies, and sprains.

Warnings

For external use only.

Flammable. Keep away from fire or flame

Do Not Use

  • on wounds or damaged skin
  • if epileptic 
  • with high blood pressure

When Using This Product

  • avoid contact with the eyes. 
  • do not bandage tightly

Stop Use And Ask A Doctor If

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. 

If Pregnant Or Breast-Feeding,

do not use this product.

Keep Out Of Reach Of Children.

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

Directions

  • Adults and children 12 years of age and older: Apply to affected area

Dosage & Administration

      not more than 3 to 4 times daily.

  • Children under 12 years of age: consult a doctor. 

Inactive Ingredients

Anthemis nobilis flower oil, eucalyptus oil, lavender oil, melaleuca leucadendron cajaput oil, origanum majorana leaf oil, peppermint oil, prunus armeniaca (apricot) kernel oil, rosmarinus officinalis (rosemary) leaf oil, tocopherol, and vitis vinifera (grape) seed oil.

Questions?

1-877-275-7253

Other

Distributed by: SAJE NATURAL WELLNESS 500-88 E. Pender St. Vancouver, BC Canada V6A 3X3 | saje.com | 1-877-275-7253 | Made by our friends in Canada

DO NOT USE IF SECURITY SEAL AROUND BOTTLE IS BROKEN OR MISSING.

SKU 415401

Disposal And Waste Handling

We support recycling.  Please recycle where possible. 

Pain Release Topical Analgesic Massage Oil

Saje® Natural Wellness

Pain Release

Topical Analgesic Massage Oil

6.8 fl. oz. | 200 ml and 1.4 fl.oz | 40ml

* Please review the disclaimer below.