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| Product NDC Code | 70983-004 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Pain release |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | GRANULE | ||||||||
| 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.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. 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, 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 by dissolving 2 teaspoons of salt soak in warm water and soaking area
Purpose
Information about the drug product’s indications for use.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 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.Pain Release Bath Salt Soak 120 g Saje Natural Wellness Pain Release Pain Relieving Bath Salt Soak net wt. 4.2 oz. | 120 g image description
Pain Release Bath Salt Soak 620 g Saje® Natural Wellness Pain Release Pain Relieving Bath Salt Soak net wt. 21.9 oz. | 620 g image description
Pain Release Pain Relieving Bath Salt Soak net wt. 10.6 oz. | 300 g Saje Natural Wellness Pain Release Pain Relieving Bath Salt Soak net wt. 10.6 oz. | 300 g PAINRELEASE_300g_Bath Salt_Tub_705607_USA_FINAL.jpeg
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.Pain Release 620 g DO NOT USE IF SAJE SEAL ON BOTTLE'S OPENING IS BROKEN OR MISSING. SKU 427901
Pain Release 120 g DO NOT USE IF TEAR NOTCH SECURITY SEAL ON ZIPPERED BAG INSIDE IS DAMAGED OR MISSING SKU 423501
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 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Distributed by: SAJE NATURAL WELLNESS 500-88 E. Pender St. Vancouver, BC Canada V6A 3X3 | saje.com | 1-877-275-7253 | Made in Canada
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.
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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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.
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