Label: CANNARELIEF 1000MG- menthol salve

  • NDC Code(s): 82876-010-49
  • Packager: Carolina Cannabis Creations LLC
  • 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 August 1, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Menthol...........11.3%

    Purpose

    Menthol 11.3%.........................Topical Analgesic

    Purpose

    Menthol 11.3%.........................Topical Analgesic

  • Uses

    Temporary relief of aches and pains associated with arthritis, backache, joint pain, muscle strains, and sprains

  • Warnings

    FOR EXTERNAL USE ONLY, provides penetrating pain relief

  • When using this product

    Do not apply to wounds or irritated skin, and avoid contact with eyes

  • Stop use and ask a doctor if

    The condition worsens, symptoms last more than 7 days, the condition clears but occurs again within a few days, Rash or irritation occurs

    Stop use and ask a doctor if

    Condition worsens, Symptoms last more than 7 days, Condition clears up but occurs again within a few days, Rash or irritations occurs

  • If pregnant or breastfeeding

    Consult a health professional before use

    In case of an overdose

    seek medical help or contact a poison control center right away

  • Directions

    Adults and children 12 years and over; apply to the affected area one to four times daily

    Children 12 years and younger; ask a doctor

    Keep out of reach of children

    keep out of reach of children

    Keep out of reach of children

    keep out of reach of children

  • Other information

    Store at 68-77 degrees F, Avoid direct sunlight

  • Inactive ingredients

    Arnica Montana oil, Arrowroot powder, Beeswax, Cannabidiol, Coconut oil, Rice bran oil, Rosemary oil, and Shea butter.

  • Front label

    front label

  • Back label

    back label

  • INGREDIENTS AND APPEARANCE
    CANNARELIEF 1000MG 
    menthol salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82876-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.9 g  in 71.9 g
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M) 5.17 g  in 71.9 g
    PEG-8 BEESWAX (UNII: 3C1QUF1TIR) 19.2 g  in 71.9 g
    COCONUT OIL (UNII: Q9L0O73W7L) 8.33 g  in 71.9 g
    ROSEMARY OIL (UNII: 8LGU7VM393) 0.59 g  in 71.9 g
    RICE BRAN OIL (UNII: LZO6K1506A) 12.2 g  in 71.9 g
    SHEA BUTTER (UNII: K49155WL9Y) 12.3 g  in 71.9 g
    CANNABIDIOL (UNII: 19GBJ60SN5) 1.13 g  in 71.9 g
    ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR) 4.22 g  in 71.9 g
    MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A) 0.86 g  in 71.9 g
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82876-010-4971.9 g in 1 TUBE; Type 0: Not a Combination Product08/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2023
    Labeler - Carolina Cannabis Creations LLC (118697474)
    Registrant - Carolina Cannabis Creations LLC (118697474)
    Establishment
    NameAddressID/FEIBusiness Operations
    Carolina Cannabis Creations LLC118697474manufacture(82876-010)