Coralite Extra Strength Cool And Hot
FDA Label NDC 65923-145

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 Cool And Hot (NDC 65923-145). 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 - pregnancy or breast feeding, otc - when using, otc - keep out of reach of children, indications & usage, storage and handling, 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 5%........................................................................... Topical analgesic

Otc - Purpose

Uses

Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • bruises
  • cramps

Warnings

Warnings

For external use only

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use

Otc - When Using

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

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 12 years of age and older
  • peel off protective backing and apply sticky side to affected area
  • carefully remove backing from patch
  • should be used up to 8 hours
  • should be used no more than 3 times a day
  • children 12 years of age consult a doctor

Storage And Handling

Other information

  • store at room temperature, not to exceed 86°F (30°C)

Inactive Ingredient

Inactive ingredients

aloe vera, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monostearate, polysorbate 80, polyvinyl alcohol, polyvinylpyrrolidone, purified water, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate, Release Liner: polypropylene, non-woven material: polyester non-woven fabric

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 (90145)

Image Description (90145)

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