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  5. Label Information: Coralite Muscle And Joint Pain Relief

FDA Label for Coralite Muscle And Joint Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - WHEN USING
    5. OTC - STOP USE
    6. OTC - PREGNANCY OR BREAST FEEDING
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. INDICATIONS & USAGE
    9. INACTIVE INGREDIENT
    10. DOSAGE & ADMINISTRATION
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Coralite Muscle And Joint Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product United Exchange Corp.. 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.

Otc - Active Ingredient



Active ingredient                                                                Purpose

Capsaicin 0.15%............................................................. Topical analgesic


Otc - Purpose



Uses

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings



Warnings

For external use only


Otc - When Using



When using this product

  • read inside of carton before using
  • use only as directed
  • do not bandage tightly or cover treated area
  • do not use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds, damaged, broken or irritated skin
  • a mild burning sensation may occur upon application but generally disapperas in several days
  • if severe burning sensation occurs, discontinue use immediately and read information printed inside carton
  • do not expose the area treated with product to heat or direct sunlight

Otc - Stop Use



Stop use and ask a doctor if

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

    • Flammable keep away from fire or flame


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding ask a health professional before use.


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.


Indications & Usage



Directions

adults and children over 18 years:

  • apply to affected area
  • place the applicator on the skin and press firmly to dispense the liquid
  • massage into painful area until thoroughly absorbed
  • repeat if necassary, but no more than 3 to 4 times daily
  • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

    • children 17 years or younger: consult a physician


Inactive Ingredient



Inactive ingredients

alcohol, carbomer 940, glycerin, propylene glycol, triethanolamine, water


Dosage & Administration



Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in China


* Please review the disclaimer below.