Road to Wellness

Manufacturer
Saje Natural Business Inc. | Natures Formulae Health Products Ltd.
Effective date
2016-10-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:47

Label at a glance#

ProductRoad to Wellness
Active ingredientMENTHOL
Label structure27 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

Kit Contains 3 SAJE FAVORITES:

TRAUMA LESS topical analgesic ointment

PAIN RELEASE topical analgesic oil blend

peppermint halo COOLING & SOOTHING OIL BLEND FOR THE HEAD

IMPORTANT: FOR EACH PRODUCT, READ ALL PRODUCT INFORMATION ON OUTER AND INNER BOX FLAP BEFORE USING.  KEEP THIS PACKAGE FOR FULL INFORMATION.

DO NOT USE IF THE FOLLOWING SECURITY FEATURES ARE BROKEN OR MISSING:

SEAL AROUND TIN (OINTMENT) | SEAL AROUND BOTTLE (OIL BLENDS)

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

We support recycling.  Please recycle where possible

SKU 22280201

LIFT HERE TO CONTINUE TO READ IMPORTANT PRODUCT INFORMATION ON ALL PRODUCTS.

GET READY FOR WELLNESS

Drug FactsActive ingredient 

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.27%

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 allergic to plants of the asteraceae/compositae/daisy family.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a doctor before use.

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 times daily.

  • Not recommended for children under 12 years of age.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Arnica montana flower extract, beeswax (yellow), olive oil, and peppermint oil. 

PAIN RELEASE - topical analgesic oil blend 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.

Pain Release - topical analgesic oil blend

SPL UNCLASSIFIED SECTION

Apply to muscles & joints experiencing minor aches & pains, as directed:

A - Shoulders

B - Neck

C - Back (upper/middle/lower)

D - Elbows

E - Hands

F - Soles of Feet

G - Hips

H - Thighs

I - Knees

J - Calves

SOOTHING OIL BLEND peppermint halo COOLING & SOOTHING OIL BLEND FOR THE HEAD

SPL UNCLASSIFIED SECTION

Apply to the following areas:

A - Along hairline

B - Neck

C - Shoulders

Directions for use: Apply as desired to entire hairline, creating a halo effect. Apply to neck and shoulders for extra cooling and relaxation. Avoid eyes and mucous membranes. For prolonged use, consult a doctor.

Ingredients: Mentha piperita (peppermint) oil, eucalyptus globulus leaf oil, melaleuca leucadendron cajaput oil, rosmarinus officinalis (rosemary) leaf oil, lavandula angustifolia (lavender) oil, and vetiveria zizanoides root oil.

Warnings:

  • Keep out of reach of children.
  • For external use only. if swallowed, seek urgent care/call poison control.
  • If skin sensitization occurs, rinse with vegetable oil.
  • Avoid eyes & mucous membranes; if contact occurs, rinse with vegetable oil.
  • Do not use if pregnant/breastfeeding, with high/low blood pressure, or if epileptic.
  • If allergic reaction occurs, stop use & consult a doctor.

SPL UNCLASSIFIED SECTION

Saje is committed to providing 100% natural products containing pure essential oils and ingredients derived from mineral and botanical sources. Saje products are not tested on animals and do not contain any artificial or synthetic chemicals, preservatives, fragrances or colors. 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ROAD TO WELLNESS

cooling relief convenience kit

1 TOPICAL ANALGESIC OINTMENT 0.47 OZ. | 13.5 g

1 TOPICAL ANALGESIC OIL BLEND 0.2 FL.OZ. | 6 mL

1 OIL BLEND 0.2 FL.OZ. | 6 mL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1813422menthol 1.27 % Topical OintmentPSN1
1813422menthol 0.0127 MG/MG Topical OintmentSCD1
1813422menthol 1.27 % Topical OintmentSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-017-19Road to Wellness1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70983-017ROAD TO WELLNESS (MENTHOL) KIT [SAJE NATURAL BUSINESS INC.]1Legacy NDC, 1 package rows20161025_d0bb6139-391e-4a44-bfe6-e065208c6843.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70983-01770983-017-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

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
0cf78c45-128b-4144-a1a5-902c632a1d2ed0bb6139-391e-4a44-bfe6-e065208c68432016-10-11WarningsExact identifier
spl id: 0cf78c45-128b-4144-a1a5-902c632a1d2e
spl set id: d0bb6139-391e-4a44-bfe6-e065208c6843

Reported adverse events (FAERS/openFDA)#

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