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  5. Label Information: Kinesys Analgesic Sport

FDA Label for Kinesys Analgesic Sport

View Indications, Usage & Precautions

Table of Contents

    1. RECOMMENDED USE
    2. DURATION OF USE
    3. STORAGE AND HANDLING
    4. MEDICINAL INGREDIENTS (PER DOSE UNIT)
    5. NON-MEDICINAL INGREDIENTS
    6. ADULTS, ADOLESCENTS
    7. CHILDREN 2-12 YEARS OLD
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. OTC - WHEN USING
    10. OTC - STOP USE
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - ASK DOCTOR/PHARMACIST
    13. KNOWN ADVERSE REACTIONS
    14. PRINCIPAL DISPLAY PANEL - 50 G CYLINDER LABEL

Kinesys Analgesic Sport Product Label

The following document was submitted to the FDA by the labeler of this product Wilc Healthcare Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Recommended Use



Temporarily relieves aches and pains of muscles and joints associated with one or more of the following: backache, strains and sprains (involving muscles, tendons, and/or ligaments), and arthritis.


Duration Of Use



Consult a health care practitioner for use beyond 7 days.


Storage And Handling



  • Store protected from direct light and moisture at room temperature.

    • Store protected from direct light and moisture at room temperature.


Medicinal Ingredients (Per Dose Unit)



Methyl salicylate 30%, Menthol (l-Menthol, Mentha arvensis - Herb top) 15%.


Non-Medicinal Ingredients



Propylene glycol, PEG-8, Ethyl alcohol, Sodium stearate, Aqua, D&C Green No. 5.


Adults, Adolescents



1-4 time(s) per day. Apply thinly and evenly to affected area up to 3 to 4 times per day. Rub and/or massage into skin until solution vanishes. For external use only. Avoid contact with the eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not tightly bandage. Do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn.


Children 2-12 Years Old



1-4 time(s) per day. Application should be supervised by an adult. Apply thinly and evenly to affected area up to 3 to 4 times per day. Rub and/or massage into skin until solution vanishes. For external use only. Avoid contact with the eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not tightly bandage. Do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn.


Otc - Keep Out Of Reach Of Children



Keep out of the reach of children.


Otc - When Using



If overdose or accidental ingestion occurs, call a Poison Control Center immediately.


Otc - Stop Use



Discontinue use and consult a health care practitioner if symptoms persist and/or worsen after 7 days or re-occur within a few days.


Otc - Pregnancy Or Breast Feeding



Consult a healthcare practitioner prior to use if you are pregnant or breastfeeding .


Otc - Ask Doctor/Pharmacist



Consult a healthcare practitioner prior to use if you are taking anticoagulant medications.


Known Adverse Reactions



Rashes and/or burning discomfort have been known to occur; in which case, discontinue use. Hypersensitivity such as allergy has been known to occur; in which case, discontinue use.


Principal Display Panel - 50 G Cylinder Label



KINeSYS®

Analgesic
SPORT STICK

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