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 structure16 sections

Dosage and administration

Adults and children 12 years of age and older: Apply to affected area by dissolving 2 teaspoons of salt soak in warm water and soaking area

Label contents#

Full prescribing information#

DRUG FACTS Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.16%

OTC - PURPOSE SECTION

Purpose External Analgesic

Uses For the temporary relief of pain and itching associated with scrapes, insect bites, and minor skin irritations.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • if epileptic 
  • with high blood pressure

When using this product,

OTC - WHEN USING SECTION

avoid contact with the eyes. 

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 by dissolving 2 teaspoons of salt soak in warm water and soaking area

DOSAGE & ADMINISTRATION SECTION

      not more than 3 to 4 times daily.

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Anthemis nobilis flower oil, cinnamomum camphora (camphor) bark oil, corn starch, epsom salt, eucalyptus oil, lavender oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, sea salt, and sodium bicarbonate.

OTC - QUESTIONS 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 620 g

SPL UNCLASSIFIED SECTION

DO NOT USE IF SAJE SEAL ON BOTTLE'S OPENING IS BROKEN OR MISSING.

SKU 427901

Pain Release 120 g

SPL UNCLASSIFIED SECTION

DO NOT USE IF TEAR NOTCH SECURITY SEAL ON ZIPPERED BAG INSIDE IS DAMAGED OR MISSING

SKU 423501

Pain Release Bath Salt Soak 620 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Saje® Natural Wellness

Pain Release 

Pain Relieving Bath Salt Soak

net wt. 21.9 oz. | 620 g

image descriptionimage description

Pain Release Bath Salt Soak 120 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Saje® Natural Wellness

Pain Release 

Pain Relieving Bath Salt Soak

net wt. 4.2 oz. | 120 g

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69204-005-06Pain Release620 g in 1 BOTTLE, PLASTICGRANULE6202
69204-005-07Pain Release1 in 1 PACKETGRANULE12
69204-005-07Pain Release120 g in 1 POUCHGRANULE1202
69204-005-08Pain Release300 g in 1 BOTTLE, PLASTICGRANULE3002

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69204-00569204-005-06, 69204-005-07, 69204-005-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTUS OIL2R04ONI662IACT
LAVENDER OILZBP1YXW0H8IACT
SWEET MARJORAM OILICH7BE016EIACT
PEPPERMINT OILAV092KU4JHIACT
ROSEMARY OIL8LGU7VM393IACT
SEA SALT87GE52P74GIACT
SODIUM BICARBONATE8MDF5V39QOIACT
MENTHOLL7T10EIP3AACTIB
CHAMAEMELUM NOBILE FLOWER OILUB27587839IACT
CAMPHOR OIL75IZZ8Y727IACT
STARCH, CORNO8232NY3SJIACT
MAGNESIUM SULFATE HEPTAHYDRATESK47B8698TIACT

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.781d3c8d-7b70-e973-e053-2991aa0aaa782025-12-29WarningsExact identifier
ndc (package): 69204-005-08
ndc (package): 69204-005-06
ndc (package): 69204-005-07
ndc (product): 69204-005
ndc11 (package): 69204000506
ndc11 (package): 69204000507
ndc11 (package): 69204000508
spl id: 471f5c2f-0e22-8065-e063-6394a90a1be4
spl set id: 781d3c8d-7b70-e973-e053-2991aa0aaa78

Reported adverse events (FAERS/openFDA)#

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