FDA.reportPublic FDA data

Coralite Pain Relief

Manufacturer
United Exchange Corp.
Effective date
2017-07-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:14:49

Label at a glance#

ProductCoralite Pain Relief
Active ingredientMENTHOL
Label structure12 sections

Storage and handling

Other Information store at room temperature, not to exceed 86°F (30°C)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                                        Purpose

Menthol 5%.............................................. Topical Analgesic

OTC - PURPOSE SECTION

Uses

Temporarily relives minor aches and pains of muscles and joints due to:

  • arthritis
  • simple backache
  • muscle strains
  • bursitis
  • tendonitis
  • muscle sprains
  • bruises
  • cramps

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • conditions worsens
  • symptoms persist for more than 7 days or clears up and occurs again within a few days
  • redness is present
  • skin irritation 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 hep or contact a Poision Control Center right away.

INDICATIONS & USAGE SECTION

Directions

Adults and children 12 years of age and older

  • peel off protective backing and apply sticky side to affected area
  • carefully remove backing from patch
  • should be used up to 8 hours
  • should be used no more than 3 times a day
  • children under 12 years of age: consult a doctor

STORAGE AND HANDLING SECTION

Other Information

  • store at room temperature, not to exceed 86°F (30°C)

INACTIVE INGREDIENT SECTION

Inactive Ingredients

aloe vera gel, BHT, castor oil, concentrated glycerin, disodium edetate hydrate, dried aluminum hydroxide gel, gelatin, isopropyl myristate, kaolin, magnesium aluminosilicate, methylparaben, PEG monostearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate

DOSAGE & ADMINISTRATION SECTION

DISTRIBUTED BY:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703 USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
MENTHOLACTIVE MOIETYL7T10EIP3A2
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN02
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q9412
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6622
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
POLYACRYLIC ACID (8000 MW)INACTIVE INGREDIENT73861X4K5F2
PROPANEDIOLINACTIVE INGREDIENT5965N8W85T2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65923-15065923-150-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
GLYCERINPDC6A3C0OXIACT
EDETATE DISODIUM7FLD91C86KIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
GELATIN2G86QN327LIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
KAOLIN24H4NWX5COIACT
ALMASILATEOZQ8O62H53IACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
WATER059QF0KO0RIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 227 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALUMINUM HYDROXIDEALUMINUM HYDROXIDE5QB0T2IUN0CREAM / TOPICAL5 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSPRAY / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHFILM, SOLUBLE / BUCCAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAMUSCULAR6 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SUSPENSION / ORAL75 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRALESIONAL0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE / ORAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / NASAL14 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRALESIONAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TEMULSION / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALUMINUM HYDROXIDEALUMINUM HYDROXIDE5QB0T2IUN0TABLET / ORAL50 mgExact identifier — unii candidate
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / VAGINAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUPPOSITORY / VAGINALNAExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION, CONCENTRATE / ORAL0.2 mg/1mlExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER / ORALNAExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / EPIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / IONTOPHORESIS0.1 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / VAGINAL3 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHJELLY / TOPICAL180 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / RECTAL1808 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, EXTENDED RELEASE / ORAL0.17 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAVENOUS6 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHEMULSION / TOPICAL0.06 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / SUBCUTANEOUS22 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INFILTRATION80 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHJELLY / NASAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCONCENTRATE / ORAL2.5 mg/5mlExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates

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
d3c4bc0e-9966-3e68-e053-2a95a90aa3a868ae68ea-6c73-4b3b-aef1-749e8bddd4c22021-12-22WarningsExact identifier
spl set id: 68ae68ea-6c73-4b3b-aef1-749e8bddd4c2

Reported adverse events (FAERS/openFDA)#

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