Coralite Cold And Hot
FDA Label NDC 65923-153

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 Cold And Hot (NDC 65923-153). 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 - pregnancy or breast feeding, 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

Menthol 5%................................................... Topical analgesic

Otc - Purpose

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:

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

Warnings

Warnings

For external use only

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 mebranes
  • do not apply to wounds or damaged skin

Otc - Stop Use

Stop use and ask a doctor if:

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • skin 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 Poision 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 under 12 years of age: consult a doctor

    • Other Information

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

Inactive Ingredient

Inactive ingredients

aloe vera gel, BHT, castor oil, concentrated glycerin, disodium edetate hydrate, dried aluminum hydroxide gel, gelatin, isopropyl myristate, kaolin, magnesium aluminosilicate, methylparaben, PEG, monostearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate

Dosage & Administration

DISTRIBUTED BY:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703 USA

Package Label.Principal Display Panel

Image Description (90153)

Image Description (90153)

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