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  5. Label Information: Coralite Extra Strength Cool And Hot

FDA Label for Coralite Extra Strength Cool And Hot

View Indications, Usage & Precautions

Table of Contents

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

Coralite Extra Strength Cool And Hot 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

Menthol 5%........................................................................... Topical analgesic


Otc - Purpose



Uses

Temporarily relieves minor pain associated with:

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

Warnings



Warnings

For external use only


Otc - Pregnancy Or Breast Feeding



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


Otc - When Using



When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

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 12 years of age and older
  • peel off protective backing and apply sticky side to affected area
  • carefully remove backing from patch
  • should be used up to 8 hours
  • should be used no more than 3 times a day
  • children 12 years of age consult a doctor

Storage And Handling



Other information

  • store at room temperature, not to exceed 86°F (30°C)

Inactive Ingredient



Inactive ingredients

aloe vera, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monostearate, polysorbate 80, polyvinyl alcohol, polyvinylpyrrolidone, purified water, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate, Release Liner: polypropylene, non-woven material: polyester non-woven fabric


Dosage & Administration



DISTRIBUTED BY:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703 USA

MADE IN KOREA


Package Label.Principal Display Panel



image description - 90145

image description - 90145


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