Label: TRUVITALITY CBD MUSCLE FREEZE 4% MENTHOL- menthol gel

  • Category: HUMAN OTC DRUG LABEL

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 31, 2019

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  • ACTIVE INGREDIENT

    Menthol 4%.

  • DOSAGE & ADMINISTRATION

    Adults and children over 2 years: Rub a thin film over affected areas up to 4 times daily. Children under 2 years: Consult a physician.

  • WARNINGS

    Warnings: For external use only.

    When using this product: Use only as directed. Do not bandage tightly. Do not use a heating pad or device. Avoid contact with the eyes and mucous membranes. Do not apply to wounds or damaged, broken or irritated skin. Do not use with other ointments.

    Flammable: Keep away from excessive heat or flame.

    These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

  • INACTIVE INGREDIENT

    Aloe Juice, Cannabidiol (Hemp Derived, THC-Free), Carbomer, Glycerin, MCT Coconut Oil, PhenoxyEthanol, Propylene Glycol, Water.

  • INDICATIONS & USAGE

    Uses: Menthol provides temporary relief from minor aches and pains of sore muscles & joints associated with: simple backache, strains, sprains, bruises, cramps.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

  • PURPOSE

    Menthol 4%: Cooling Pain Relief.

  • STOP USE

    Stop use and ask a doctor if: Condition worsens, irritation develops, symptoms persist for over 7 days or clear up and reoccur within a few days.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding: Ask a health professional before use.

  • STORAGE AND HANDLING

    Do not freeze. Keep lid tightly closed when not in use. Store in a cool place.

  • QUESTIONS

    Questions or Comments?: 1-800-214-4064.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    TRUVITALITY CBD MUSCLE FREEZE 4% MENTHOL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73155-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE (UNII: V5VD430YW9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CANNABIS SATIVA SUBSP. SATIVA WHOLE (UNII: 0XTN3895NP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73155-004-311 in 1 BOX01/30/2020
    13 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/30/2020
    Labeler - TRUVITALITY, LLC (117075021)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deenterprises, Inc.073070083manufacture(73155-004) , pack(73155-004) , label(73155-004)
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