Coralite Medicated Heat Patch
FDA Label NDC 65923-123

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 Medicated Heat (NDC 65923-123). 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 - when using, otc - stop use, 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

Capsicum Extract Capsaicin 0.025%..............................Topical Analgesic

Otc - Purpose

Uses

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

  • Simple Backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains

Warnings

Warnings

For external use only

Discontinue use at lease one hore before a shower or bath and do not use immediately after a shower or bath

Otc - Do Not Use

Do not use:

  • on wounds or damaged skin.
  • with a heating pad.
  • with, or at the same times as, other external analgesic products.
  • if you are allergic to any ingredients of this product.

Otc - When Using

When using this product:

  • do not use otherwise than directed.
  • avoid contact with the eyes, mucous membranes or rashes.

Otc - Stop Use

stop use and ask a doctor if:

  • rash, itching or excessive skin irritation develops.
  • conditions worsen.
  • symptoms persist for more than 7 days.
  • symptoms 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 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 for 7 days.
  • Remove patch from skin after at more 8 hours of application.

    • Children Under 12 Years of Age: Consult a physician.

Storage And Handling

Other information

  • Avoid storing product in direct sunlight.
  • Protect product from excessive moisture.

Inactive Ingredient

Inactive ingredients

butylhydroxytoluene, glyceryl rosinate, isopropyl myristate, natural rubber, polybutene, polyisobutylene, precipitated calcium carbonate, propylene carbonate, sorbitan stearate, terpene resin (quinton), terpene resin (YS resin), titanium oxide, zinc oxide

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 (90132a)

Image Description (90132a)

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