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Pain release - Medication Information

Product NDC Code 69204-005
Drug Name

Pain release

Type Brand
Active Ingredients
Menthol 1.6 mg/g
Route TOPICAL
Dosage Form GRANULE
Application Number part348
Labeler Name Natures Formulae Health Products Ltd.
Packages
Package NDC Code Description
69204-005-06 620 g in 1 bottle, plastic (69204-005-06)
69204-005-07 1 pouch in 1 packet (69204-005-07) / 120 g in 1 pouch
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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 620 g Saje® Natural Wellness Pain Release Pain Relieving Bath Salt Soak net wt. 21.9 oz. | 620 g image description 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

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 feeding
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.

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