Coralite Pain Relief Patch
FDA Label NDC 65923-564

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 Pain Relief (NDC 65923-564). 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 - do not use, otc - stop use, otc - when using, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients Purpose

Camphor 1.2%........................................Topical Analgesic

Menthol 5.7%..........................................Topical Analgesic

Methyl Salicylate 6.3%............................Topical Analgesic

Otc - Purpose

Uses

For temporary relief of minor aches & pains of muscles & joints associated with:

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product

Otc - Stop Use

Stop use and ask a doctor if

  • rash, itching or excessive skin irritation develops
  • condition worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

Otc - When Using

When using this product

  • do not use other than directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or conduct a Poision Control Center right away

Indications & Usage

Directions

adults and children 12 years of age and over:

  • clean and dry affected area
  • remove patch from film
  • apply to affected area not more than 3 to 4 times daily
  • remove patch from the skin after at most 8 hours' application

    • children under 12 years of age:

    • consult a doctor

Storage And Handling

Other information

  • avoid storing product in direct sunlight
  • protect from excessive moisture

Inactive Ingredient

Inactive ingredients

lanolin, natural rubber, petrolatum, polyisobutylene, rosin, zinc oxide

Dosage & Administration

Distributed by:

United Exchange Corp.

5836 Corporate Ave.

Suite 200

Cypress, CA 90630 USA

Made in China

* Please review the disclaimer below.