FDA.reportPublic FDA data

Assured Cold'n Hot Medicated Patch 2ct 6159, 2020

Manufacturer
Greenbrier International, Inc
Effective date
2020-10-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:34:07

Label at a glance#

ProductAssured Cold N Hot Pain Relief Menthol
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 5%--------------------------------------------------------- Topical analgestic

OTC - PURPOSE SECTION

Uses

Temporarily relieves minor pains associated with:

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

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • 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 as only directed
  • avoid contact with eyes and mucous membranes
  • 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

  • condition worsens or symptoms persist more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

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

  • ​open pouch and remove patch
  • carefully peel off protective packing and apply sticky side to affected area
  • adults and children 12 years of age and older:
  • do not wear patch for more than 8 hours
  • apply to affected area no more than 3 times daily
  • 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

Inactive ingredients

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

DOSAGE & ADMINISTRATION SECTION

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY

CHESAPEAKE, VA 23320

MADE IN KOREA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

6159.16159.1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN4
420222menthol 0.05 MG/MG Medicated PatchSCD4
420222menthol 5 % Medicated PatchSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33992-6159-52024-01-30C16284748780-11030e365-4a79-111a-e063-dadaa90a10e2Assured Cold'n Hot Medicated Patch 2ct 6159, 2020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33992-6159-5Assured Cold N Hot Pain Relief Menthol5 mg in 1 POUCHPATCH54
33992-6159-5Assured Cold N Hot Pain Relief Menthol2 in 1 PACKETPATCH24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33992-6159ASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]4Legacy NDC, 2 package rows20201124_21de1eeb-a54e-426d-ac2e-a93a2db860db.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
MENTHOLACTIVE MOIETYL7T10EIP3A2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN02
CASTOR OILINACTIVE INGREDIENTD5340Y2I9G2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
GELATININACTIVE INGREDIENT2G86QN327L2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS2
KAOLININACTIVE INGREDIENT24H4NWX5CO2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q6212
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J9902
SODIUM POLYACRYLATE (8000 MW)INACTIVE INGREDIENT285CYO341L2
TARTARIC ACIDINACTIVE INGREDIENTW4888I119H2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
33992-615933992-6159-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
CASTOR OILD5340Y2I9GIACT
EDETATE DISODIUM7FLD91C86KIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
KAOLIN24H4NWX5COIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
METHYLPARABENA2I8C7HI9TIACT
POLYETHYLENE GLYCOL 1000U076Q6Q621IACT
POLYSORBATE 806OZP39ZG8HIACT
POLYVINYL ALCOHOL532B59J990IACT
WATER059QF0KO0RIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MENTHOLL7T10EIP3AACTIB
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT

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 9 · 514 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.4 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
78 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COSYRUP / ORAL10 mg/1mlExact identifier — unii candidate
13 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSUSPENSION / ORAL5000 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / RESPIRATORY (INHALATION)0.03 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990AEROSOL, FOAM / VAGINAL0.5 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, COATED / ORAL0.7 mgExact identifier — unii candidate
17 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HENEMA / RECTAL0.01 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / SUBCUTANEOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HELIXIR / ORAL2.5 mg/15mlExact identifier — unii candidate
78 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPASTE, DENTIFRICE / DENTAL0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLIQUID / INTRAVENOUS720 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
78 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / VAGINAL22 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSHAMPOO, SUSPENSION / TOPICAL3 %w/vExact identifier — unii candidate
40 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, COATED / ORAL0.9 mgExact identifier — unii candidate
16 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / VAGINAL8 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSYSTEM / TOPICAL420 mgExact identifier — unii candidate
40 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COCAPSULE, EXTENDED RELEASE / ORAL21 mgExact identifier — unii candidate
13 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HINJECTION, SOLUTION / INTRAMUSCULAR18 mgExact identifier — unii candidate
24 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / INTRAVENOUS900 mgExact identifier — unii candidate
78 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TELIXIR / ORAL800 mgExact identifier — unii candidate
79 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPDROPS / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GOINTMENT / TOPICAL14.9 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
POLYETHYLENE GLYCOL 1000POLYETHYLENE GLYCOL 1000U076Q6Q621SOLUTION / ORAL1000 mg/5mlExact identifier — unii candidate
9 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COPOWDER / TOPICAL10056 mgExact identifier — unii candidate
13 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / RESPIRATORY (INHALATION)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii candidate
40 equally ranked IID candidates
POLYETHYLENE GLYCOL 1000POLYETHYLENE GLYCOL 1000U076Q6Q621CREAM / TOPICAL0.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
78 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAVENOUS45 mgExact identifier — unii candidate
79 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
17 equally ranked IID candidates
POLYETHYLENE GLYCOL 1000POLYETHYLENE GLYCOL 1000U076Q6Q621SUPPOSITORY / VAGINALNAExact identifier — unii candidate
9 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYSTEM / TOPICAL42 mgExact identifier — unii candidate
79 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED / ORAL288 mgExact identifier — unii candidate
44 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET / ORAL1.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUPPOSITORY / VAGINAL28 mgExact identifier — unii candidate
78 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS4739 mgExact identifier — unii candidate
78 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
b2bf31ce-d06a-e357-e053-2a95a90a987a21de1eeb-a54e-426d-ac2e-a93a2db860db2020-10-28WarningsExact identifier
spl id: b2bf31ce-d06a-e357-e053-2a95a90a987a
spl set id: 21de1eeb-a54e-426d-ac2e-a93a2db860db

Reported adverse events (FAERS/openFDA)#

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