ROAD TO WELLNESS- menthol kit

Road to Wellness by

Drug Labeling and Warnings

Road to Wellness by is a Otc medication manufactured, distributed, or labeled by Saje Natural Business Inc., Natures Formulae Health Products Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Facts Active ingredient 

Menthol 1.27%

PURPOSE

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

For external use only.

Flammable. Keep away from fire or flame.

Do not use 

• on wounds or damaged skin
• if allergic to plants of the asteraceae/compositae/daisy family.

When using this product

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

Stop use and ask a doctor

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,

ask a doctor before use.

Keep out of reach of children.

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

Directions

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

DOSAGE & ADMINISTRATION

     not more than 3 times daily.

• Not recommended for children under 12 years of age.

Inactive ingredients

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

PAIN RELEASE - topical analgesic oil blend Drug Facts Active ingredient 

Menthol 1.98%

PURPOSE

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

For external use only. 

Flammable. Keep away from fire or flame.

Do not use

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

When using this product,

• avoid contact with the eyes
• do not bandage tightly

Stop use and ask a doctor 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, 

do not use this product

Keep out of reach of children.

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

Directions

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

DOSAGE & ADMINISTRATION

     not more than 3 to 4 times daily

• Not recommended for children under 12 years of age

Inactive ingredients

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

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

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. 

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

INGREDIENTS AND APPEARANCE

ROAD TO WELLNESS 
menthol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70983-017

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70983-017-19	1 in 1 KIT	10/16/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 CANISTER	13.5 g
Part 2	1 BOTTLE, DROPPER	6 mL
Part 3	1 BOTTLE, DROPPER	6 mL

Part 1 of 3

TRAUMA LESS 
menthol ointment

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	12.7 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
YELLOW WAX (UNII: 2ZA36H0S2V)
OLIVE OIL (UNII: 6UYK2W1W1E)
PEPPERMINT OIL (UNII: AV092KU4JH)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		13.5 g in 1 CANISTER; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/16/2016

Part 2 of 3

PAIN RELEASE 
menthol oil

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	17.62 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CAJUPUT OIL (UNII: J3TO6BUQ37)
SWEET MARJORAM OIL (UNII: ICH7BE016E)
PEPPERMINT OIL (UNII: AV092KU4JH)
ROSEMARY OIL (UNII: 8LGU7VM393)
GRAPE SEED OIL (UNII: 930MLC8XGG)

Product Characteristics
Color	white (clear)	Score
Shape	FREEFORM (oil)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		6 mL in 1 BOTTLE, DROPPER; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/16/2016

Part 3 of 3

PEPPERMINT HALO 
other skin care preparations

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	PEPPERMINT OIL (UNII: AV092KU4JH)
INGR	EUCALYPTUS OIL (UNII: 2R04ONI662)
INGR	CAJUPUT OIL (UNII: J3TO6BUQ37)
INGR	ROSEMARY OIL (UNII: 8LGU7VM393)
INGR	LAVENDER OIL (UNII: ZBP1YXW0H8)
INGR	VETIVER OIL (UNII: 9M9P32M01L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		6 mL in 1 BOTTLE, DROPPER; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/16/2016

Labeler - Saje Natural Business Inc. (203413380)

Establishment
Name	Address	ID/FEI	Business Operations
Natures Formulae Health Products Ltd.		241385587	manufacture(70983-017)