Label: JOINT-RITIS PAIN RELIEVING ROLL-ON- menthol ointment

  • NDC Code(s): 83623-161-02, 83623-161-22
  • Packager: Lifeline Naturals of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 27, 2023

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

  • Drug Facts

  • Active ingredient

    Menthol 16% w/v

  • Purpose

    Pain reliever

  • Uses

    temporarily relieves minor aches and pains of muscles and joints due to arthritis • simple backache • sprains • strains • bruises

  • Warnings

    For external use only

    When using this product
    • avoid contact with the eyes or mucous membranes; if product gets into eyes, rinse thoroughly with water
    • do not apply to wounds or damaged skin
    • do not bandage tightly
    • do not use with electric heating pads

    Stop use and ask a doctor if
    • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
    • a rash or irritation develops

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 12 years of age and older: Apply a small amount gently into affected area not more than three to four times daily
    • shake well before use
    • children under 12 years of age: Do not use, consult a doctor

  • Other information

    • because product is all-natural, consistency may change with temperature variations
    • if thickening occurs, run bottle under warm water or warm in palms of hands
    • store at room temperature, protected from light and heat

  • Inactive ingredients

    Chondroitin Sulfate, Copaiba Balsam (Copaifera officinalis) Resin Oil, D-Glucosamine Sulfate, Eucalyptus Oil, Lanolin, Lavender Oil, Olive-Pomace Oil

  • Questions or comments?

    +1-954-532-5390
    You may also report serious side effects to phone number.
    Mon - Thu: 8:30 AM - 5:30 PM

  • SPL UNCLASSIFIED SECTION

    ORIGINAL FORMULA

    MAXIMUM STRENGTH
    100% NATURAL
    ALCOHOL-FREE ROLL-ON

    Distributed by:
    Lifeline Naturals of America
    325 SW 15th Ave.,
    Pompano Beach, FL 33069

    (954)532--5390
    ask@realjointritis.com
    www.realjointritis.com

    PAIN RELIEF THAT’S EASY ON YOUR SKIN

    Introducing JOINT-RITIS®, the ultimate solution for relieving minor joint pain. This remarkable topical pain reliever goes deep beneath the surface to provide you with penetrating pain relief.

    Unlike other topical analgesics that dry the skin, JOINT-RITIS® contains skin conditioners Lanolin, Glucosamine, & Chondroitin to keep the skin hydrated. And now, we've taken it to the next level with maximum strength Menthol for pain-relief

    Lot # & Expiry located on the bottom of the container

    All Natural Menthol Joint Pain Relief Ointment Also For Muscle Aches & Strains, Neck & Lower Back Pain

  • Packaging

    rollon

  • INGREDIENTS AND APPEARANCE
    JOINT-RITIS PAIN RELIEVING ROLL-ON 
    menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83623-161
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM16 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    COPAIBA OIL (UNII: 64VX45Y68N)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83623-161-021 in 1 BOX09/01/2023
    1NDC:83623-161-2259 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01709/01/2023
    Labeler - Lifeline Naturals of America, Inc. (056248953)