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  5. Label Information: Pain Relieving

FDA Label for Pain Relieving

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS:
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE:
    6. WHEN USING THIS PRODUCT:
    7. STOP USE AND ASK A DOCTOR IF:
    8. KEEP OUT OF REACH OF CHILDREN:
    9. DIRECTIONS:
    10. OTHER INFORMATION:
    11. INACTIVE INGREDIENTS:
    12. DESCRIPTION
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    14. PRODUCT PACKAGE PAIN RELIEVING GEL

Pain Relieving Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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.

Active Ingredients



Active Ingredients                   
Menthol 3.5%


Purpose



Cooling Pain Relief


Uses



Temporary relief from minor aches and pains of sore muscles and joints associated with • arthritis • backache • strains • sprains


Warnings:



For external use only


Ask A Doctor Before Use If You Have:



sensitive skin, are pregnant or breast feeding


When Using This Product:



• Avoid contact with eyes or mucous membranes 

• Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops

• Do not bandage or use with heating pad or device. ointments, creams, sprays. liniments

• Wash hands after with cool water


Stop Use And Ask A Doctor If:



Condition worsens. symptoms persist more than 7 days, or clear up and recur


Keep Out Of Reach Of Children:



If ingested, get medical help. Contact Poison Control Center immediately.


Directions:



• Adults / Children 2 years and older: Massage onto affected area up to 4 times daily.  • Children under 2 years of age: Consult physician


Other Information:



Store in cool dry place, lid closed tightly. keep away from excessive heat or open flame.


Inactive Ingredients:



Water, isopropyl alcohol, herbal extract (IIex paraguariensis), menthol, carbomer, triethanolamine, silicon dioxide, methylparaben, glycerine, propylene glycol, FDandC blue #1


Description



0  96295  11511  6  LOT  Distributed By: Cardinal Health, Dublin, OH 43017  www.myleader.com


Package Label.Principal Display Panel



NDC 37205-824-26  EXTRA STRENGTH Pain Relieving Gel  Provides Hours of Long Lasting Relief from:  Arthritis - Backache  Sore Muscles - Stiff Joints  Fast Acting  Greaseless  Vanishing Scent  SATISFACTION  GUARANTEED  4 FL OZ (118 mL)

Drug Facts  Distributed By: Cardinal Health, Dublin, OH 43017  www.myleader.com


Product Package Pain Relieving Gel



Pain Relieving Gel A - PainRelievingGelA

Pain Relieving Gel A - PainRelievingGelA


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