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 structure15 sections

Dosage and administration

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

Contacts and useful links#

PhoneLabel contact1-877-275-7253

Label contents#

Full prescribing information#

DRUG FACTS Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.37%

OTC - PURPOSE SECTION

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

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.

Children under 12 years of age: consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

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 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Saje® Natural Wellness

Pain Release

Topical Analgesic Massage Oil

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

Pain release 40ml massage oil label

image description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69204-008-10	Pain Release	200 mL in 1 BOTTLE, DROPPER	OIL	200	2
69204-008-10	Pain Release	1 in 1 BOX	OIL	1	2
69204-008-11	Pain Release	40 mL in 1 BOTTLE, PLASTIC	OIL	40	2
69204-008-12	Pain Release	100 mL in 1 BOTTLE, PLASTIC	OIL	100	2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Pain Release
Menthol
CHAMAEMELUM NOBILE FLOWER OIL
EUCALYPTUS OIL
LAVENDER OIL
CAJUPUT OIL
SWEET MARJORAM OIL
PEPPERMINT OIL
APRICOT KERNEL OIL
ROSEMARY OIL
TOCOPHEROL
GRAPE SEED OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69204-008	69204-008-10, 69204-008-11, 69204-008-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CHAMAEMELUM NOBILE FLOWER OIL	UB27587839	IACT
EUCALYPTUS OIL	2R04ONI662	IACT
LAVENDER OIL	ZBP1YXW0H8	IACT
CAJUPUT OIL	J3TO6BUQ37	IACT
SWEET MARJORAM OIL	ICH7BE016E	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
APRICOT KERNEL OIL	54JB35T06A	IACT
ROSEMARY OIL	8LGU7VM393	IACT
TOCOPHEROL	R0ZB2556P8	IACT
GRAPE SEED OIL	930MLC8XGG	IACT
MENTHOL	L7T10EIP3A	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Release	MENTHOL	Natures Formulae Health Products Ltd.	781dfd66-f006-a2d7-e053-2991aa0a170c	2025-12-29	Warnings	Exact identifier ndc (package): 69204-008-10 ndc (package): 69204-008-11 ndc (package): 69204-008-12 ndc (product): 69204-008 ndc11 (package): 69204000812 ndc11 (package): 69204000811 ndc11 (package): 69204000810 spl id: 471f7065-fab9-8af4-e063-6394a90a2157 spl set id: 781dfd66-f006-a2d7-e053-2991aa0a170c

Reported adverse events (FAERS/openFDA)#

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