Coralite Ultra Strength Pain Relief Ointment
FDA Label NDC 65923-532

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 Ultra Strength Pain Relief (NDC 65923-532). 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 - ask doctor, 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 ingredients                                                       Purpose

Camphor 11%........................................................ Topical analgesic

Menthol 11%.......................................................... Topical analgesic

Otc - Purpose

Uses

For temporary relief of minor aches and pains of muscles and joints associated with overexertion, simple backache, arthritis, strains, and sprains

Warnings

Warnings

For external use only

Otc - When Using

When using this product

  • Avoid contact with the eyes and mucous membranes
  • Do not apply to open wounds or damaged skin
  • Do not bandage or use heating pad

Otc - Ask Doctor

Stop use and ask a doctor if

  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than seven days
  • Pain clears up and then recurs a few days later

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a healthcare 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 immediately

Indications & Usage

Directions

  • For adults and children under 12, rub well on the affected area. Repeat 3 to 4 times daily.
  • For children 12 years of age or younger, consult a healthcare professional before use.

Storage And Handling

Other information

This product may cause allergic reaction in some individuals. Test on small area before use.

Inactive Ingredient

Inactive ingredients

clove oil, paraffin, peppermint oil, petrolatum

Dosage & Administration

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in China

* Please review the disclaimer below.