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  5. Label Information: Miracle Plus Overnight Pain Relieving

FDA Label for Miracle Plus Overnight Pain Relieving

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - WHEN USING
    8. OTC - STOP USE
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 113 G BOTTLE LABEL

Miracle Plus Overnight Pain Relieving 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

  • do not apply to wounds or damaged skin
  • do not bandage tightly

    • Manufactured by Concept Laboratories, Inc., Chicago, IL 60642 #BG-MP9874


Active Ingredient



Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)


Purpose



Pain Relieving


Uses



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

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises

Warnings



For external use only.


Otc - Do Not Use



  • Do not use with heating pad, wrap, hot water bottle or any heating element.

Otc - When Using



When using this product do not get into eyes

  • avoid contact with other mucous membranes

Otc - Stop Use



Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or 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

Otc - Pregnancy Or Breast Feeding



  • 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

Other Information



  • It is recommended to test for skin sensitivity prior to use. Apply product to a small area, follow the directions and wait 24 hours. Proceed with application if no adverse reaction.
  • A burning sensation may occur upon initial application but generally disappears with continued use. For a severe burning discomfort, remove excess product with a soft cloth and cooking oil.
  • If applying product to hands, wait 30 minutes before washing.
  • Avoid water, heat, or direct sunlight while using product.
  • If wearing contact lenses, insert prior to application and avoid touching them after applying product.
  • If eye contact occurs, flush immediately with water.

Inactive Ingredients



Water (Aqua), Glycerin, PEG-75 Lanolin, Aloe Barbadensis Leaf Juice, PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Polysorbate 20, Glucosamine HCI, Emu Oil, Dimethyl Sulfone, Celosia Argentea Seed Extract, Ginkgo Biloba Extract, Panax Ginseng Root Extract, Medicago Sativa (Alfalfa) Extract, Cymbopogon Schoenanthus Extract, Tocopheryl Acetate, DMDM Hydantoin, Propylene Glycol, Methylparaben, Propylparaben.


Questions Or Comments?



Call 1-888-373-8831 or visit www.conceptlabs.org


Principal Display Panel - 113 G Bottle Label



MIRACLE®
PLUS

OVERNIGHT

PAIN RELIEVING
GEL

odor-free
pain relief

IMMEDIATE
RELIEF

* Please review the disclaimer below.