Label: TRIVITA QPR- menthol, unspecified form gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 22, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Natural Menthol, USP (8.5%)

  • Purpose

    Topical Analgesic

  • Uses

    Temporary relief from minor aches and pains from sore muscles and joints, backache, and arthritis.

  • 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.

  • 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 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.

  • 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.

  • SPL UNCLASSIFIED SECTION

    distributed by TriVita, Inc.,
    16100 N. Greenway Hayden Loop,
    Suite 950, Scottsdale, AZ 85260 USA.

  • 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
  • INGREDIENTS AND APPEARANCE
    TRIVITA QPR 
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76571-313
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM8.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Arnica Montana Flower (UNII: OZ0E5Y15PZ)  
    Indian Frankincense (UNII: 4PW41QCO2M)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)  
    Glucosamine Sulfate (UNII: 1FW7WLR731)  
    Glycerin (UNII: PDC6A3C0OX)  
    Ilex Paraguariensis Leaf (UNII: 1Q953B4O4F)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    MethylParaben (UNII: A2I8C7HI9T)  
    Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76571-313-3088 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2020
    Labeler - TriVita, Inc. (128295040)
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