Label: STRESSA BACK AND NECK PAIN RELIEVING- menthol oil

  • 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 4, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Menthol 1.25%

  • Purpose

    topical analgesic

  • Uses

    For the temporary relief of pain associated with

    • simple backache
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only.

    When using this product

    • avoid contact with eyes
    • do not bandage tightly,

    Stop use and ask a doctor if

    • conditions worsen or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days

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

  • 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 a doctor.

  • Inactive ingredients

    almond oil, alpha tocopherol (vitamin E), apricot kernel oil, arabica coffee oil, basil oil, cananga oil, european hazelnut oil, galbanum oil, hyssop oil, lemon juice, methyl salicylate, nutmeg oil, picea mariana leaf oil, pine needle oil (pinus sylvestris), rosemary oil, sage oil, wheat germ

  • PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label

    Stressa™

    back & neck
    pain relieving oil

    all natural formula
    for the soothing relief
    of tense and sore
    muscles

    NET WT
    8 fl oz (240 mL)

    Principal Display Panel - 240 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    STRESSA BACK AND NECK PAIN RELIEVING 
    menthol oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53882-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol1 g  in 93 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALMOND OIL (UNII: 66YXD4DKO9)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    BASIL OIL (UNII: Z129UMU8LE)  
    ARABICA COFFEE OIL (UNII: IK55HKE887)  
    GALBANUM OIL (UNII: 211UF7M8N1)  
    EUROPEAN HAZELNUT OIL (UNII: 8RQ2839AVG)  
    HYSSOP OIL (UNII: 173D71924B)  
    LEMON OIL (UNII: I9GRO824LL)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SAGE OIL (UNII: U27K0H1H2O)  
    PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
    PICEA MARIANA LEAF OIL (UNII: Q1J49L1A5O)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    WHEAT GERM (UNII: YR3G369F5A)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    CANANGA OIL (UNII: 8YOY78GNNX)  
    Product Characteristics
    ColorORANGE (Clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53882-002-0160 mL in 1 BOTTLE, PLASTIC
    2NDC:53882-002-02118 mL in 1 BOTTLE, PLASTIC
    3NDC:53882-002-03240 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34808/01/2014
    Labeler - Stressa Incorporated (031377428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Stressa Incorporated031377428MANUFACTURE(53882-002)
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