Otc - Active Ingredient
Drug Facts
Active ingredient Purpose
Lidocaine 4%..........................................................Topical anesthetic
The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp for the product Coralite Lidocaine 4% Flexible Pain Relief Patch 1ct (NDC 65923-579). 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.
Drug Facts
Active ingredient Purpose
Lidocaine 4%..........................................................Topical anesthetic
Uses temporarily relieves pain
Warnings For external use only.
Do not use
more than one patch at a time on wounds or damaged skin
for more than one week without consulting a doctor
if you are allergic to any ingredients of this product
When using this product
use only as directed do not allow contact with the eyes
do not bandage tightly or apply local heat (such as heating pads)
to the area of use
avoid the patch getting wet for better adhesion
dispose of used patch in manner that always keeps product away
from children or pets. Used patches still contain the drug product
that can produce serious adverse effects if a child or pet chews or
ingests this patch.
Stop use and ask a doctor if
condition worsens redness is present
symptoms persist for more than 7 days or clear up and occur
again within a few days discontinue use of this product and
consult a doctor
irritation develops
you experience signs of skin injury, such as pain, swelling, or
blistering where the product was applied.
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 breast-feeding, ask a health professional before use.
Directions
adults and children 12 years:
clean and dry affected area
remove film from patch and apply to the skin (see illustrations)
apply to affected area no more than 3 to 4 times daily
remove patch from the skin after at most 8-hour application
children under 12 years of age: consult a doctor
Other information
store at room temperature 20-25°C (68-77°F)
Inactive ingredients
distillates (petroleum), hydrotreated heavy naphthenic, hydrogenated
C6-20 Polyolefin (100 CST), isopropyl myristate, pentaerythritol
tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate),
polystyrene-block-polyisoprene-block-polystyrene, propylene glycol,
tris(2,4-di-tert-butylphenyl)phosphite
Questions or comments?
Call 1-888-645-8204 Monday-Friday 9AM-5PM (PST)
*This product is not manufactured or distributed by
Hisamitsu America Inc., a subsidiary of Hisamitsu
Pharmaceutical Co. Inc., distributor of Salonpas® Pain
Relieving FLEX Patch Lidocaine.
Distributed by: UNITED EXCHANGE CORP.
Cypress, CA 90630 USA | 1-888-645-8204
Made in China | 90221-ZDP-PH-R1 | PR-TP-ZDP202-R1
* Please review the disclaimer below.