PAIN RELIEF ROLLER SIGNATURE CARE (MENTHOL 4%) GEL [BETTER LIVING]

PAIN RELIEF ROLLER SIGNATURE CARE (MENTHOL 4%) GEL [BETTER LIVING]
PDF | XML

NDC 21130-764-03
Set ID 01ab3464-256a-4caa-9efb-c30c98dbe102
Category HUMAN OTC DRUG LABEL
Packager Better Living
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredient                                                        Purpose
    Menthol 4%...............................................................Topical anesthetic

  • PURPOSE

  • Uses

    For the temporary relief from minor aches and pains of soar muscles and joints associated with arthritis, backache, strains and sprains

  • WARNINGS

    Warnings
    For external use only.

    Flammable: Do not use while smoking or near heat or flame
    When using this product  • avoid contact with eyes or mucouse membranes•do not apply to wounds or damaged skin • do not apply to the irritated skin • do not bandage • wash hands after use with cool water • do not use with heating pad or device.

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions
    Shake well. Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of
    age: consult a doctor.

  • Inactive ingredients

    Aloe Barbadensis Leaf Extract
    Arctium Lappa Root (Burdock) Extract
    Arnica Montana Flower Extract
    Boswellia Carterii Resin Extract
    Calendula Officinalis Extract
    Camellia Sinensis Leaf Extract
    Camphor
    Carbomer
    FD&C Blue #1
    FD&C Yellow #5
    Glycerin
    Ilex Paraguariensis (Mate) Leaf Extract
    Isopropyl Alcohol
    Isopropyl Myristate
    Melissa Officinalis (Lemon Balm) Leaf Extract
    Silica
    Tocopheryl Acetate
    Triethanolamine
    Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF ROLLER  SIGNATURE CARE
    menthol 4% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-764
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    Glycerin (UNII: PDC6A3C0OX)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-764-0373 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package03/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/30/2018
    Labeler - Better Living (009137209)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(21130-764) , label(21130-764)

Related Drugs