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Muscle and joint pain relief gr isolate 150 mg - Prescription Drug Labeling

Product NDC Code 78232-004
Drug Name

Muscle and joint pain relief gr isolate 150 mg

Type Brand
Active Ingredients
Menthol 4 g/100g
Methyl salicylate 10 g/100g
Route TOPICAL
Dosage Form CREAM
Application Number part346
Labeler Name Clarity Labs LLC
Packages
Package NDC Code Description
78232-004-03 120 box in 1 carton (78232-004-03) > 30 tube in 1 box (78232-004-02) > 30 g in 1 tube (78232-004-01)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Methyl Salicylate 10% w/w. Purpose: Topical Analgesic Menthol 4% w/w. Purpose: Topical Analgesic

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.
Directions This product is for external use only. Place enough on one hand to cover the affected area and rub the area accordingly. Apply to affected area no more than 3 to 4 times daily.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Bentonite, Carthamus tinctorius Oleosomes, Cucumis sativus Fruit Extract, Ethylhexylglycerin, Glycerin, Hemp Derived Cannabinoid Extract, Lavandula angustifolia Oil, Persea gratissima Oil, Phenoxyethanol, Rosmarinus o­fficinalis Oil, Tocopherol, Xanthan Gum, Water.

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.
Use Pain relief cream to help reduce minor aches and pains of muscles and joints associated with: arthritis, strains, sprains, simple backaches, and bruises.

Purpose

Information about the drug product’s indications for use.
Purpose Topical Analgesic, pain relief cream

Spl product data elements

Usually a list of ingredients in a drug product.
Muscle and Joint pain relief GR Isolate 150 mg PAIN RELIEF LAVENDER OIL CUCUMBER WATER CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES .ALPHA.-TOCOPHEROL ETHYLHEXYLGLYCERIN MENTHOL MENTHOL PHENOXYETHANOL AVOCADO OIL CANNABIDIOL BENTONITE METHYL SALICYLATE SALICYLIC ACID CHAMOMILE

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.
Design and Label of BOX Tube Label 150 tube label Package Label Outer Box IFC IFC Individual Folding Carton 150_IFC-label Most outer BOX Big Container BOX 150 most outer

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.
This Pain Relief Cream has been formulated with methyl salicylate and menthol to help with aches and pains, and then added CBD, rosemary oil, vitamin E and more to create a truly unique cream for the wellbeing of muscles and joints.

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 in children on open skin wounds

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 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.
Manufacturing and Distributors information MANUFACTURED AND DISTRIBUTED BY: GREEN ROADS OF FLORIDA, LLC 601 FAIRWAY DR, DEERFIELD BEACH, FL 33441 833-462-8922 GREENROADS.COM

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 irritation or rash occurs. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product, and consult a physician.

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.
This product is for external use only. When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Do not bandage tightly when applying this product. Do not apply this product more than 4 times per day. Stop use and ask a doctor if irritation or rash occurs. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Storage and handling

Information about safe storage and handling of the drug product.
Other information Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

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.
Avoid contact with eyes Do not bandage tightly Do not apply to wounds or damaged skin For external use only

Disclaimer: Do not rely on openFDA 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