Q HEALTH PAIN RELIEF (MENTHOL) LIQUID [QCAN INTERNATIONAL INC.]

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Q HEALTH PAIN RELIEF (MENTHOL) LIQUID [QCAN INTERNATIONAL INC.]
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NDC 54102-000-04
Set ID aa6d1beb-f462-4577-a57c-fb0ec12d4ce5
Category HUMAN OTC DRUG LABEL
Packager QCAN International Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • Q Health Pain Relief Spray

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  • Active Ingredient:

    Menthol  8.00%

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  • Purpose

    External Analgesic

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  • Directions:

    Apply directly to affected area.  Do not use more than four times per day.

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  • Uses:

    For temporary relief of minor aches and pains associated with simple backache, arthritis, bruises and sprains.

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  • Warnings:

    • For external use only.
    • Avoid contact with eyes.
    • Do not bandage tightly.

    Do not apply

    on open wounds or damaged skin.

    Discontinue use

    If symptoms persist more than seven days, discontinue use and consult physician.

    Keep out of reach of children.

    If swallowed, consult physician.

    If pregnant or breast feeding,

    contact physician prior to use.

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  • Other Ingredients:

    Aqua (Deionized Water), Arnica Montana Extract, Boswella Serrata Extract, Bromelain, Chondroitin Sulfate, Citric Acid, Dimethyl Sulfone (MSM), Eucalyptus Globulus Oil, Glucosamine Sulfate, Glycrrhiza Glabra (Licorice) Extract, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Magnesium Sulfate, Mentha Piperita (Peppermint) Oil, Methylisothiazolinone, Polysorbate-20, Polysorbate-80, Propylene Glycol, SD-Alcohol 40B.

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  • PRINCIPAL DISPLAY PANEL

    Q Health PAIN Relief Spray   Fast temporary relief of minor aches and pains   associated with simple backache arthritis, strains, bruises, sprains    Contains Magnesium and Glucosamine Chondroitin MSM  www.qcan.ca     4 FL OZ (120ML)   Manufactured for   QCAN INTERNATIONAL   1581 Crimson Cres.  Kingston ON, K7P 0J3   Canada.

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  • Product Labels

    Pain Relief SprayI nnerPain Relief Spray Outer

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  • INGREDIENTS AND APPEARANCE
    Q HEALTH PAIN RELIEF 
    menthol liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54102-000
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 80 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    BROMELAINS (UNII: U182GP2CF3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54102-000-04 1 in 1 CARTON 02/07/2017
    1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 09/13/2012
    Labeler - QCAN International Inc. (246834035)
    Establishment
    Name Address ID/FEI Business Operations
    Pure Source, LLC 080354456 manufacture(54102-000)
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