Otc - Active Ingredient
Drug Facts
Active ingredient Purpose
Capsicum extract 0.083% as Capsaicin........Topical analgesic
Menthol 3%....................................................Topical analgesic
The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corporation for the product Coralite Pain Relief Hot (NDC 65923-146). 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.
Drug Facts
Active ingredient Purpose
Capsicum extract 0.083% as Capsaicin........Topical analgesic
Menthol 3%....................................................Topical analgesic
Uses
temporarily relieves minor pain of muscles and joints associated with:
Warnings
For external use only
Allergy alert: Do not use if you are allergic to capsicum, chili peppers, or any ingredients in this product.
Do not use
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Other information
Inactive ingredients alcohol, aluminum glycinate, glycerin, kalin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide
Questions or comments?
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Distributed By: UNITED EXCHANGE CORPORATION
Cypress, CA 90630 USA | 1-888-645-8204
Made In China
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