Label: PAIN RELIEF SIGNATURE CARE- menthol 10.5% spray

  • 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 January 22, 2018

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  • ACTIVE INGREDIENT

    Active ingredient                                                            Purpose
    Menthol 10.5%..............................................................Topical Analgesic

  • PURPOSE

  • INDICATIONS & USAGE

    Uses Temporary relief from minor aches and pains of sore 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 the eyes or mucous
    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, or if symptoms
    persist for more than 7 days, or clear up and reoccur.

  • 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

  • DOSAGE & ADMINISTRATION

    Directions • 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 physician.

  • INACTIVE INGREDIENT

    Inactive ingredients Alcohol Denat., Arnica Montana Flower
    Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf
    Extract, Chamomile Recutita Flower Extract, Dimethyl Sulfone, Echinacea
    Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate,
    Juniperus Communis Fruit Extract, Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  SIGNATURE CARE
    menthol 10.5% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-333
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol10.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    JUNIPER BERRY (UNII: O84B5194RL)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-333-0385 g in 1 CAN; Type 0: Not a Combination Product03/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/30/2018
    Labeler - Better Living Brands (009137209)
    Registrant - Product Quest Mfg. (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg.927768135manufacture(21130-333) , label(21130-333)