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  5. Label Information: Coralite Extra Strength Pain Relief Sleeve Wrist

FDA Label for Coralite Extra Strength Pain Relief Sleeve Wrist

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 - KEEP OUT OF REACH OF CHILDREN
    7. INDICATIONS & USAGE
    8. INACTIVE INGREDIENT
    9. DOSAGE & ADMINISTRATION
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Coralite Extra Strength Pain Relief Sleeve Wrist 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 16.0%.......................................Topical Analgesic Patch


Otc - Purpose



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

  • arthritis
  • strains
  • bruises
  • sprains

Warnings



Warnings

For external use only


Otc - When Using



When using this product

  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pad

Otc - Stop Use



Stop use and ask a doctor if redness is present or irritation develops, 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 immediately.


Indications & Usage



Directions

  • Adults and children over 12 years: pull sleeve onto wrist, knee, small ankles or elbows until the colored section of the sleeve is positioned directly over the affected area. Sleeve should feel snug but not tight.

    • Apply one sleeve to the affected area; not more than 4 times daily.

    • Children 12 years of younger: consult a doctor.

Inactive Ingredient



Inactive ingredients

carbomber 940, ethanol, ethylparaben, glycerol, propylene glycol, purified water, trolamine


Dosage & Administration



Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in China


* Please review the disclaimer below.