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Product NDC Code | 76571-313 | ||||
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Drug Name | Trivita qpr |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
Application Number | part348 | ||||
Labeler Name | TriVita, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Natural Menthol, USP (8.5%)
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 only as directed. Do not use on children under 12 years of age. Roll onto affected area no more than four times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Camphor, Cannabis Sativa Seed Oil (Hemp Derived), Carbomer, Chondroitin Sulfate, Glucosamine Sulfate, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Methyl Paraben, Methylsulfonylmethane, Peppermint Oil, Polysorbate 20, Propylene Glycol, Purified Water, Triethanolamine.
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 Temporary relief from minor aches and pains from sore muscles and joints, backache, and arthritis.
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.TRIVITA QPR MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM Aloe Vera Leaf Arnica Montana Flower Indian Frankincense CANNABIS SATIVA SEED OIL Carbomer Homopolymer, Unspecified Type Glucosamine Sulfate Glycerin Ilex Paraguariensis Leaf Isopropyl Alcohol MethylParaben Dimethyl Sulfone Peppermint Oil Polysorbate 20 Propylene Glycol Water Trolamine
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.PRINCIPAL DISPLAY PANEL - 88 ml Bottle Label TRIVITA QPR QUICK PAIN RELIEF SOOTHING MENTHOL FORMULA FOR FAST-ACTING TEMPORARY RELIEF OF MINOR ACHES & PAINS ~{ EASY ROLL-ON APPLICATOR!}~ 150 MG CBD CONTAINS BROAD-SPECTRUM THC-FREE HEMP CBD 3FL OUNCES (88 ml) PRINCIPAL DISPLAY PANEL - 88 ml Bottle 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
distributed by TriVita, Inc., 16100 N. Greenway Hayden Loop, Suite 950, Scottsdale, AZ 85260 USA.
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.Flammable: Keep out of reach of children. Contact a doctor before using if you have sensitive skin or are pregnant, breastfeeding or on any medications. If swallowed get medical help or call poison control center immediately.
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 redness or irritation occurs, if condition worsens, or if pain persists for more than 7 days or clears up, then reoccurs.
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 Do not use with heating pad or on heated skin. Do not bandage. Do not apply to wounds or damaged skin. Wash hands with cold water immediately after use, and do not touch eyes or mucous membranes.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Questions call 1-800-991-7116. Store in a cool, dry place with the cap tightly closed. Note: Because this product contains natural ingredients, colors may vary.
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 out of reach of children. Contact a doctor before using if you have sensitive skin or are pregnant, breastfeeding or on any medications. If swallowed get medical help or call poison control center immediately. When using this product Do not use with heating pad or on heated skin. Do not bandage. Do not apply to wounds or damaged skin. Wash hands with cold water immediately after use, and do not touch eyes or mucous membranes. Stop use and ask a doctor if redness or irritation occurs, if condition worsens, or if pain persists for more than 7 days or clears up, then reoccurs.
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