FDA.reportPublic FDA data

Coralite Muscle & Joint Pain Relief patch 2ct (90155)

Manufacturer
United Exchange Corporation
Effective date
2023-01-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:53:23

Label at a glance#

ProductCoralite Muscle and Joint Pain Relief
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE
Label structure15 sections

Storage and handling

store at room temperature 20-25°C (68-77ºF) avoid storing product in direct sunlight protect product from excessive moisture

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purposes

Camphor 1.2%...................Topical analgesic

Menthol 5.7%.....................Topical analgesic

Methyl salicylate 6.3%.......Topical analgesic

OTC - PURPOSE SECTION

Uses

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

WARNINGS SECTION

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

OTC - DO NOT USE SECTION

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
  • 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

  • do not use otherwise than as directed
  • avoid contact with 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

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

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:
  • clean and dry affected area
  • remove patch from film
  • apply to affected area no more than 3 to 4 times daily
  • do not wear patch for more than 4 hours
  • children under 12 years of age: consult a doctor

STORAGE AND HANDLING SECTION

  • store at room temperature 20-25°C (68-77ºF)
  • avoid storing product in direct sunlight
  • protect product from excessive moisture

INACTIVE INGREDIENT SECTION

Inactive ingredients

aluminum silicate, butylated hydroxytoluene, glyceryl rosinate, lanolin, natural rubber, paraffin, polyisobutylene (80000 mw), polyisobutylene (85000 mw), styrene-isoprene-styrene block copolymer, titanium dioxide, zinc oxide

OTC - QUESTIONS SECTION

Call 1-888-645-8204 Monday-Friday 9AM-5PM (PST)

DOSAGE & ADMINISTRATION SECTION

Distributed By:

UNITED EXCHANGE CORP.

Cypress, CA. 90630 USA

Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

9015590155

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchPSN1
853260camphor 0.012 MG/MG / menthol 0.057 MG/MG / methyl salicylate 0.063 MG/MG Medicated PatchSCD1
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65923-163-022025-01-30C16284748780-12cef2736-6234-d83d-e063-dadaa90ab31fCoralite Muscle & Joint Pain Relief patch 2ct (90155)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-163-02Coralite Muscle and Joint Pain Relief1 in 1 POUCHPATCH11
65923-163-02Coralite Muscle and Joint Pain Relief1 g in 1 PATCHPATCH11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-163CORALITE MUSCLE AND JOINT PAIN RELIEF (CAMPHOR, MENTHOL, AND MEHTYL SALICYLATE) PATCH [UNITED EXCHANGE CORPORATION]12 package rows20230120_f22d143d-1576-8de3-e053-2a95a90a4b58.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65923-16365923-163-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMERK7S96QM8DVIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ZINC OXIDESOI2LOH54ZIACT
POLYISOBUTYLENE (85000 MW)7X53O5S2ZYIACT
PARAFFINI9O0E3H2ZEIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
NATURAL LATEX RUBBER2LQ0UUW8INIACT
GLYCERYL ROSINATESD112V492JIACT
ALUMINUM SILICATET1FAD4SS2MIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
LANOLIN7EV65EAW6HIACT
POLYISOBUTYLENE (800000 MW)Y132ZOQ9H7IACT

Source Document#

Source XML

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
f22d1431-569c-6b25-e053-2a95a90a2866f22d143d-1576-8de3-e053-2a95a90a4b582023-01-13WarningsExact identifier
spl id: f22d1431-569c-6b25-e053-2a95a90a2866
spl set id: f22d143d-1576-8de3-e053-2a95a90a4b58

Reported adverse events (FAERS/openFDA)#

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