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| Product NDC Code | 70983-017 | ||||
|---|---|---|---|---|---|
| Drug Name | Road to wellness |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 1813422 | ||||
| Application Number | part348 | ||||
| Labeler Name | Saje Natural Business Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredient Menthol 1.27%
PAIN RELEASE - topical analgesic oil blend Drug Facts Active ingredient Menthol 1.98%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Arnica montana flower extract, beeswax (yellow), olive oil, and peppermint oil.
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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Directions Adults and children 12 years of age and older: Apply to affected area
Directions Adults and children 12 years of age and older: Apply to affected area
Purpose
Information about the drug product’s indications for use.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
Spl product data elements
Usually a list of ingredients in a drug product.Road to Wellness Menthol Trauma Less Menthol MENTHOL MENTHOL ARNICA MONTANA FLOWER YELLOW WAX OLIVE OIL PEPPERMINT OIL Pain Release Menthol MENTHOL MENTHOL CHAMAEMELUM NOBILE FLOWER OIL EUCALYPTUS OIL LAVENDER OIL CAJUPUT OIL SWEET MARJORAM OIL PEPPERMINT OIL ROSEMARY OIL GRAPE SEED OIL clear oil Peppermint Halo PEPPERMINT OIL EUCALYPTUS OIL CAJUPUT OIL ROSEMARY OIL LAVENDER OIL VETIVER OIL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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 description
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.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
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.
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.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on wounds or damaged skin if allergic to plants of the asteraceae/compositae/daisy family.
Do not use on wounds or damaged skin if epileptic with high blood pressure
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right awa y.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with the eyes do not bandage tightly.
When using this product, avoid contact with the eyes do not bandage tightly
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a doctor before use.
If pregnant or breast-feeding, do not use this product
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only. Flammable. Keep away from fire or flame.
Warnings For external use only. Flammable . Keep away from fire or flame.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API