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| Product NDC Code | 70983-010 | ||||
|---|---|---|---|---|---|
| Drug Name | Pain release |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| Application Number | M017 | ||||
| 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.PAIN RELEASE topical analgesic oil blend Drug Facts Active ingredient Menthol 1.98%
PAIN RELEASE topical analgesic massage oil Drug Facts Active ingredient Menthol 1.37%
PAIN RELEASE topical analgesic mist Drug Facts Active ingredient Menthol 0.25%
PAIN RELEASE pain relieving bath salt soak Drug Facts Active ingredient Menthol 0.16%
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 to 4 times daily. Not recommended for children under 12 years of age.
not more than 3 to 4 times daily Children under 12 years of age: Consult a doctor.
not more than 3 to 4 times daily Children under 12 years of age: Consult a doctor.
by dissolving 2 teaspoons of salt soak in warm water and soaking area not more than 3 to 4 times daily. Children under 12 years of age: Consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Inactive ingredients Anthemis nobilis flower oil, eucalyptus oil, lavender oil, melaleuca leucadendron cajaput oil, origanum majorana leaf oil, peppermint oil, prunus armeniaca (apricot) kernel oil, rosmarinus officinalis (rosemary) leaf oil, tocopherol, and vitis vinifera (grape) seed 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 water.
Inactive ingredients Anthemis nobilis flower oil, cinnamomum camphora (camphor) bark oil, corn starch, epsom salt, eucalyptus oil, lavender oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, sea salt, and sodium bicarbonate.
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
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
Purpose Topical Analgesic Uses For the temporary relief of pain and itching associated with minor cuts, scrapes, or insect bites
Purpose External Analgesic Uses For the temporary relief of pain and itching associated with scrapes, insect bites, and minor skin irritations.
Spl product data elements
Usually a list of ingredients in a drug product.Pain Release Menthol Pain Release Menthol CHAMAEMELUM NOBILE FLOWER OIL EUCALYPTUS OIL LAVENDER OIL CAJUPUT OIL SWEET MARJORAM OIL PEPPERMINT OIL ROSEMARY OIL GRAPE SEED OIL MENTHOL MENTHOL clear oil Pain Release Menthol CHAMAEMELUM NOBILE FLOWER OIL EUCALYPTUS OIL LAVENDER OIL CAJUPUT OIL SWEET MARJORAM OIL PEPPERMINT OIL APRICOT KERNEL OIL ROSEMARY OIL TOCOPHEROL GRAPE SEED OIL MENTHOL MENTHOL clear oil Pain Release Menthol CHAMAEMELUM NOBILE FLOWER OIL EUCALYPTUS OIL LAVENDER OIL CAJUPUT OIL SWEET MARJORAM OIL PEPPERMINT OIL ROSEMARY OIL WATER MENTHOL MENTHOL clear liquid Pain Release Menthol CHAMAEMELUM NOBILE FLOWER OIL CAMPHOR OIL STARCH, CORN MAGNESIUM SULFATE HEPTAHYDRATE EUCALYPTUS OIL LAVENDER OIL SWEET MARJORAM OIL PEPPERMINT OIL ROSEMARY OIL SEA SALT SODIUM BICARBONATE MENTHOL MENTHOL
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.Saje Natural Wellness PAIN RELEASE KIT topical analgesic convenience kit 1 TOPICAL ANALGESIC OIL BLEND 0.34 FL.OZ. | 10 mL 1 TOPICAL ANALGESIC MASSAGE OIL 1.4 FL.OZ. | 40 mL 1 TOPICAL ANALGESIC MIST 1 FL.OZ. | 30 mL 1 TOPICAL ANALGESIC BATH SALT SOAK NET WT. 4.2 OZ. | 120 g PAIN RELEASE KIT BOX
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.GET READY FOR WELLNESS Experience relief from muscular and joint aches from backache, arthritis, sprains and strains with this pain-relieving convenience kit. Includes our popular roll-on oil blend, mist, massage oil, and bath salts. Everything you need to feel better naturally. No pain, all gain. Kit Contains 4 Saje Favorites: PAIN RELEASE topical analgesic oil blend PAIN RELEASE topical analgesic massage oil PAIN RELEASE topical analgesic mist PAIN RELEASE topical analgesic bath salt soak 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 ANY OF THE FOLLOWING SECURITY FEATURES ARE BROKEN OR MISSING: SEAL AROUND BOTTLE (OIL BLEND & MASSAGE OIL) | SEAL AROUND BOTTLE'S CAP AND NECK (MIST) | TEAR NOTCH ON ZIPPERED BAG INSIDE (SALTS) Distributed by: SAJE NATURAL WELLNESS | 500 - 88 East 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 22250701 Lift here to continue to read important product information on all products.
PAIN RELEASE topical analgesic oil blend Apply to muscles and joints experiencing minor aches and pains, as directed: A - Shoulders B - Neck C - Back D - Elbows E - Hands F - Soles of feet G - Hips H - Thighs I - Knees J - Calves
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 epileptic with high blood pressure
Do not use on wounds or damaged skin if epileptic with high blood pressure
Do not use if epileptic with high blood pressure
Do not use 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.
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 away.
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.
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
When using this product, avoid contact with the eyes.
When using this product, avoid contact with the eyes.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, do not use this product.
If pregnant or breast-feeding, do not use this product
If pregnant or breastfeeding, do not use this product
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.
Warnings For external use only.
Warnings For external use only.
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