Coralite Blue Ice
FDA Label NDC 65923-157

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 Blue Ice (NDC 65923-157). 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 - 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 ingredient                                                   Purpose

Menthol 2%........................................................Topical analgesic   

Otc - Purpose

Uses

  • temporarily relieves minor aches and pains of muscles and joints associated with:
  • arthritis
  • simple backache 
  • strains
  • bruises
  • sport injuries
  • sprains
  • provides cooling penetrating relief

Warnings

Warnings 

For external use only

Otc - Do Not Use

Do not use

  • with other topical pain relievers
  • with heating pads or heating devices

Otc - When Using

When using this product

  • do not use in or near the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • redness or irritation develops

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

  • Clean affected area before applying product
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Storage And Handling

Other information

  • store in a cool place
  • keep lid tightly closed
  • do not use, pour, spill or store near heat or open flame

Inactive Ingredient

Inactive ingredients

ammonium hydroxide, carbomer 940, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate heptahydrate, purified water, sodium hydroxide, thymol

Dosage & Administration

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 U.S.A.

www.ueccorp.com

Toll Free: 1 800 814 8028

Made in China

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