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  5. Label Information: Coralite Ultra Strength Pain Relief

FDA Label for Coralite Ultra Strength Pain Relief

View Indications, Usage & Precautions

Table of Contents

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

Coralite Ultra Strength 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 ingredients                                                       Purpose

Camphor 11%........................................................ Topical analgesic

Menthol 11%.......................................................... Topical analgesic


Otc - Purpose



Uses

For temporary relief of minor aches and pains of muscles and joints associated with overexertion, simple backache, arthritis, strains, and sprains


Warnings



Warnings

For external use only


Otc - When Using



When using this product

  • Avoid contact with the eyes and mucous membranes
  • Do not apply to open wounds or damaged skin
  • Do not bandage or use heating pad

Otc - Ask Doctor



Stop use and ask a doctor if

  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than seven days
  • Pain clears up and then recurs a few days later

Otc - Pregnancy Or Breast Feeding



If pregnant or breast feeding, ask a healthcare 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 immediately


Indications & Usage



Directions

  • For adults and children under 12, rub well on the affected area. Repeat 3 to 4 times daily.
  • For children 12 years of age or younger, consult a healthcare professional before use.

Storage And Handling



Other information

This product may cause allergic reaction in some individuals. Test on small area before use.


Inactive Ingredient



Inactive ingredients

clove oil, paraffin, peppermint oil, petrolatum


Dosage & Administration



Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in China


* Please review the disclaimer below.