FDA.reportPublic FDA data

Coralite Extra Strength Pain Relief Sleeve Knee

Manufacturer
United Exchange Corp.
Effective date
2025-10-22
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:40:28

Label at a glance#

ProductCoralite Extra Strength Pain Relief Sleeve Knee
Active ingredientMENTHOL
Label structure14 sections

Storage and handling

Other information store at room temperature 20-25°C (68-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                                                      Purpose

Menthol 16.0%..................................................Topical Analgesic Patch

OTC - PURPOSE SECTION

Uses

  • temporarily relieves minor aches and pains of muscles and joints associated with:
  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

  • on wounds or damaged skin
  • on a child under 12 years of age with arthritis-like-conditions

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • redness over the affected area

OTC - WHEN USING SECTION

When using this product

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly over sleeve or use with a heating pad
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • redness is present or irritation or rash develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

INDICATIONS & USAGE SECTION

Directions

  • adults and children 12 years of age and older:
  • open pouch and remove sleeve
  • remove plastic insert and discard
  • pull sleeve onto knee, large ankles or elbows until the colored (medicated) section of the sleeve is positioned directly over the affected area. Sleeve should feel snug, but not tight. Note: the drawings should help you understand how to do this.
  • apply one sleeve to affected area no more than 3 times daily
  • do not wear sleeve for more than 8 hours
  • children under 12 years of age: consult a doctor

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inative ingredients

carbomer 940, ethanol, ethylparaben, glycerol, propylene glycol, purified water, trolamine

DOSAGE & ADMINISTRATION SECTION

Distributed by:

United Exchange Corp.

Cypress, CA 90630 USA

Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

9012190121

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043743menthol 16 % Medicated PatchPSN8
1043743menthol 0.16 MG/MG Medicated PatchSCD8
1043743menthol 16 % Medicated PatchSY8

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130780707901212GTIN-13: 0780707901212
EAN-13: 0780707901212
GTIN-12: 780707901212
UPC-A: 780707901212
GTIN storage (14 digits): 00780707901212		90121.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-121-01Coralite Extra Strength Pain Relief Sleeve Knee1 in 1 POUCHPATCH18
65923-121-01Coralite Extra Strength Pain Relief Sleeve Knee1 in 1 BOXPATCH18

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65923-12165923-121-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
TROLAMINE9O3K93S3TKIACT
CARBOMER 9404Q93RCW27EIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
ETHYLPARABEN14255EXE39IACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-12-27full-release2026-06-01 00:49:14

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coralite Extra Strength Pain Relief Sleeve KneeMENTHOLUnited Exchange Corp.aa5873bd-af64-41cc-8f16-7714c56bca962025-10-22WarningsExact identifier
ndc (package): 65923-121-01
ndc (product): 65923-121
ndc11 (package): 65923012101
spl id: 41c4947a-9162-5e20-e063-6294a90aa3af
spl set id: aa5873bd-af64-41cc-8f16-7714c56bca96

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.