Coralite Extra Strength Pain Relief Sleeve Wrist Patch
FDA Label NDC 65923-122

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 Extra Strength Pain Relief Sleeve Wrist (NDC 65923-122). 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 - keep out of reach of children, indications & usage, inactive ingredient, 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

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.