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  5. Label Information: Pure Relief Penetrating Pain Relief

FDA Label for Pure Relief Penetrating Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - WHEN USING
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS?
    11. PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL

Pure Relief Penetrating Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Concept Laboratories, 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.

Other



Drug Facts

Manufactured by:
Concept Laboratories, Inc.
Chicago, IL 60642 (USA)
#CL10010


Otc - Purpose



Active ingredientPurpose
Capsicum Oleoresin 0.0625%Pain
(Containing Capsaicin 0.025%)Relieving

Uses



for the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings



For external use only.

  • do not apply to wounds or damaged skin

Otc - When Using



When using this product do not get into eyes

  • do not bandage tightly
  • do not use with heating pad, wrap, hot water bottle or any heating element.

Otc - Stop Use



Stop use and ask a doctor if condition worsens

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

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

  • if swallowed, get medical help or contact a Poison Control center right away
  • if pregnant or nursing, seek the advice of a health professional before using

Directions



  • Children under 12 years of age consult a physician
  • Apply a thin layer to affected area not more than 3 to 4 times daily
  • Gently massage into the skin until fully absorbed
  • Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes
  • A burning sensation may occur upon inital application but generally disappears with continued use. For a severe burning discomfort, remove excess product with a soft cloth and cooking oil.

Inactive Ingredients



Water (Aqua), Glycerin, PEG-75 Lanolin, Aloe Barbadensis Leaf Juice, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Glucosamine HCl, Medicago Sativa (Alfalfa) Extract, Ginkgo Biloba Leaf Extract, Cymbopogon Schoenanthus Extract, Seed of Celosia Argentea Extract, Dimethyl Sulfone, Panax Ginseng Root Extract, Polysorbate 20, Tocopheryl Acetate, Emu Oil, Propylene Glycol, DMDM Hydantoin. Methylparaben, Propylparaben.


Questions Or Comments?



Call toll-free 1-888-373-8831


Principal Display Panel - 118 Ml Bottle Label



Pure Relief

Penetrating
Pain Relief Spray
with Capsaicin

Temporary relieves
joint & arthritis pain in

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