Road To Wellness
FDA Label NDC 70983-017

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Saje Natural Business Inc. for the product Road To Wellness (NDC 70983-017). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, drug factsactive ingredient, otc - purpose, warnings, do not use, when using this product, stop use and ask a doctor, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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

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. 

Drug Factsactive Ingredient

Menthol 1.27%

Otc - 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.

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.

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.
    • 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,

ask a doctor before use.

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.

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 
    • 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.

    •      not more than 3 to 4 times daily

    • Not recommended for children under 12 years of age

Inactive Ingredients

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

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 Blenddrug Factsactive Ingredient

Menthol 1.98%

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.

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 Blendpeppermint 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.

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

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