FDA.reportPublic FDA data

Pain Release

Manufacturer
Natures Formulae Health Products Ltd.
Effective date
2016-10-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:49:01

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

Label contents#

Full prescribing information#

DRUG FACTS Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.25%

OTC - PURPOSE SECTION

Purpose Topical Analgesic

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

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

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 water.

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 CAP AND BOTTLE'S NECK IS BROKEN OR MISSING

SKU 376701

DISPOSAL AND WASTE HANDLING

We support recycling. Please recycle where possible.

Pain Release Topical Analgesic Mist (100 ml)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Saje® Natural Wellness

Pain Release 

Topical Analgesic Mist

3.4 fl. oz. | 100 ml

image descriptionimage description

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
69204-01169204-011-08

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
WATER059QF0KO0RIACT
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
0cfe7b08-2e9d-dc99-e063-6294a90aca46781dfd66-efbe-a2d7-e053-2991aa0a170c2023-12-20WarningsExact identifier
spl set id: 781dfd66-efbe-a2d7-e053-2991aa0a170c

Reported adverse events (FAERS/openFDA)#

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