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Product NDC Code | 73132-005 | ||||||
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Drug Name | Green compass reduce pain relief with menthol |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | GEL | ||||||
Application Number | M017 | ||||||
Labeler Name | Green Compass, Inc. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Menthol 5%
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 use as directed adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Alcohol, aqua (water), arnica montana (arnica) flower extract, Caprylhydroxamic Acid, Cinnamomum Camphora (Camphor) Bark Oil, eucalyptus globulus leaf oil, glyceryl caprylate, helianthus annuus (sunflower) seed oil, hemp flower extract (cannabigerol), hydroxyethylcellulose, lavandula angustifolia (lavender) flower oil, organic aloe barbadensis leaf juice, xanthan gum.
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.Uses For temporary relief of minor aches and pains of muscles and joints.
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Green Compass Reduce Pain Relief with Menthol Menthol XANTHAN GUM ARNICA MONTANA HYDROXYETHYL CELLULOSE, UNSPECIFIED CANNABIGEROL SUNFLOWER OIL GLYCERYL CAPRYLATE ALCOHOL MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM CAPRYLHYDROXAMIC ACID ALOE VERA LEAF EUCALYPTUS OIL LAVENDER OIL WATER CAMPHOR 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.GREEN COMPASS REDUCE PAIN RELIEF GEL with Menthol 300 mg CBG ROLL-ON 2 FL OZ (60 mL) label
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.Drug Facts Drug Facts
Distributed By: Green Compass, LLC. 1121 Military Cutoff Rd., Ste C339 Wilmington, NC 28405 USA Do not use if tamper evident seal is broken or missing. 1-833-33-MYCBD [email protected] greencompassglobal.com
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 with a heating pad
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.
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 symptoms last more than 7 days condition clears up and occurs 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
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. Do not use on wounds or damaged skin with a heating pad When using this product avoid contact with the eyes do not bandage tightly Stop use and ask a doctor if condition worsens symptoms last more than 7 days condition clears up and occurs again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.
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