FDA.reportPublic FDA data

Pain Release

Manufacturer
Natures Formulae Health Products Ltd.
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:29:18

Label at a glance#

ProductPain Release
Active ingredientMENTHOL
Label structure20 sections

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING.  KEEP THIS PACKAGE FOR FULL INFORMATION. 

DRUG FACTS Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.98%

OTC - PURPOSE SECTION

Purpose Topical Analgesic

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

Warnings

WARNINGS SECTION

For external use only.

Flammable: Keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

do not use this product.

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

      not more than 3 to 4 times daily.

  • Not recommended for children under 12 years of age.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-877-275-7253

SPL UNCLASSIFIED SECTION

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

Pain Release 30 ml

SPL UNCLASSIFIED SECTION

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

SKU 10301

Pain Release 10 ml

SPL UNCLASSIFIED SECTION

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

SKU 431201

Pain Release 6 ml

SPL UNCLASSIFIED SECTION

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

SKU 442501

Pain Release Topical Analgesic Oil Blend 30 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Saje® Natural Wellness

Pain Release

Topical Analgesic Oil Blend

1 fl. oz. | 30 ml

image descriptionimage description

Pain Release Topical Analgesic Oil Blend 10 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Saje® Natural Wellness

Pain Release

Topical Analgesic Oil Blend

0.34 fl. oz. | 10 ml

image descriptionimage description

Pain Release Topical Analgesic Oil Blend 6 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Saje® Natural Wellness

Pain Release

Topical Analgesic Oil Blend

0.2 fl. oz. | 6 ml

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69204-007-03Pain Release30 mL in 1 BOTTLE, DROPPEROIL302
69204-007-03Pain Release1 in 1 BOXOIL12
69204-007-04Pain Release1 in 1 BOXOIL12
69204-007-04Pain Release10 mL in 1 BOTTLE, DROPPEROIL102
69204-007-05Pain Release6 mL in 1 BOTTLE, DROPPEROIL62
69204-007-05Pain Release1 in 1 BOXOIL12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69204-00769204-007-03, 69204-007-04, 69204-007-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHAMAEMELUM NOBILE FLOWER OILUB27587839IACT
EUCALYPTUS OIL2R04ONI662IACT
LAVENDER OILZBP1YXW0H8IACT
CAJUPUT OILJ3TO6BUQ37IACT
SWEET MARJORAM OILICH7BE016EIACT
PEPPERMINT OILAV092KU4JHIACT
ROSEMARY OIL8LGU7VM393IACT
GRAPE SEED OIL930MLC8XGGIACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain ReleaseMENTHOLNatures Formulae Health Products Ltd.781d53cf-b3df-3e2b-e053-2a91aa0a7dcd2025-12-29WarningsExact identifier
ndc (package): 69204-007-03
ndc (package): 69204-007-05
ndc (package): 69204-007-04
ndc (product): 69204-007
ndc11 (package): 69204000705
ndc11 (package): 69204000703
ndc11 (package): 69204000704
spl id: 471f7c62-91ff-2cd8-e063-6294a90af3d9
spl set id: 781d53cf-b3df-3e2b-e053-2a91aa0a7dcd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.