Otc - Active Ingredient
Active ingredient Purpose
Capsicum Extract Capsaicin 0.025%..............................Topical Analgesic
The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Coralite Capsaicin Heat Patch 2ct (NDC 65923-809). 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 - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient Purpose
Capsicum Extract Capsaicin 0.025%..............................Topical Analgesic
Uses
For temporary relief of minor aches and pains of muscles & joints associated with:
Warnings
For external use only
Allergy alert:
Do not use:
on wounds or damaged skin.
with a heating pad.
When using this product:
do not use otherwise than directed
avoid contact with the eyes, mucous membranes or rashes
do not bandage tightly
discontinue use at least 1 hour before a bath or shower
do not use immediately after a bath or shower
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 or irritation or rash develops
a severe burning sensation occurs
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
If pregnant or breastfeeding, ask a health professional before use.
Directions
Other information
Inactive ingredients
butylated hydroxytoluene, diphenhydramine, hydrochloride, glyceryl, rosinate, lanolin, natural rubber, petrolatum, polyisobutylene (85,000 MW), styrene-isoprene-styrene block copolymer, titanium dioxide, zinc oxide
Distributed by:
United Exchange Corp.
5836 Corporate Ave.
Cypress, CA 90630 USA
Made in China
* Please review the disclaimer below.