Coralite Muscle And Joint Pain Relief Liquid
FDA Label NDC 65923-161

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Coralite Muscle And Joint Pain Relief (NDC 65923-161). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.