FDA.reportPublic FDA data

Walgreens Medicated Pain Relieving Patch 40ct (171612, 2019)

Manufacturer
WALGREENS
Effective date
2019-01-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:58:09

Label at a glance#

ProductWALGREENS MEDICATED PAIN RELIEVING
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE
Label structure15 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients                                                                                 Purpose

Camphor 1.2%......................................................................................Topical Analgesic

Menthol 5.7%........................................................................................Topical Analgesic

Methyl Salicylate 6.3%...........................................................................Topical Analgesic

OTC - PURPOSE SECTION

Uses

For temporary relief of minor aches and pains of muscles and joints associated with

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

WARNINGS SECTION

Warnings

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 directed
  • avoid contact with the 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
  • conditions 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 over:

  • 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 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)
  • avoid storing product in direct sunlight
  • protect product from excessive moisture

INACTIVE INGREDIENT SECTION

Inactive ingredients

Butylated Hydroxytoluene, Glyceryl Rosinate, Natural Rubber, Polybutene, Polyisobutylene, Precipitated Calcium Carbonate, Quinton, Sorbitan Stearate, Tocopherol Acetate, YS Resin, Zinc Oxide

OTC - QUESTIONS SECTION

Questions or comments?

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

DOSAGE & ADMINISTRATION SECTION

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

MADE IN SOUTH KOREA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

171612171612

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchPSN4
853260camphor 0.012 MG/MG / menthol 0.057 MG/MG / methyl salicylate 0.063 MG/MG Medicated PatchSCD4
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0149-402022-01-28C16284748780-1d6a99b39-841d-a426-e053-dadaa90af4c2Walgreens Medicated Pain Relieving Patch 40ct (171612, 2019)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0149-40WALGREENS MEDICATED PAIN RELIEVING20 in 1 POUCHPATCH204
0363-0149-40WALGREENS MEDICATED PAIN RELIEVING2 in 1 CARTONPATCH24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0149WALGREENS MEDICATED PAIN RELIEVING (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [WALGREENS]4Legacy NDC, 2 package rows20190110_a9721ef1-daa2-4c25-98ba-81a9965582b5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0149-40EA - Each0363-01494fff6360-4671-4d23-a7f6-79969ce0bd6412013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET3
MENTHOLACTIVE INGREDIENTL7T10EIP3A3
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y3
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET3
MENTHOLACTIVE MOIETYL7T10EIP3A3
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K3
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGK3
NATURAL LATEX RUBBERINACTIVE INGREDIENT2LQ0UUW8IN3
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58X3
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54Z3

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-01490363-0149-40

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
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
NATURAL LATEX RUBBER2LQ0UUW8INIACT
CALCIUM CARBONATEH0G9379FGKIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
ZINC OXIDESOI2LOH54ZIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

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 2 · 64 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE / ORAL349.9 mgExact identifier — unii candidate
15 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL / TOPICAL8 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE, EXTENDED RELEASE / ORAL0.03 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / RECTAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / AURICULAR (OTIC)0.38 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
15 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY / TOPICAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSOLUTION / RESPIRATORY (INHALATION)3.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XOINTMENT / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM, AUGMENTED / TOPICAL0.2 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / INTRAVENOUS4.02 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / RESPIRATORY (INHALATION)4.02 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSWAB / TOPICAL0.5 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / VAGINALNAExact identifier — unii candidate
32 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, FILM COATED / ORAL300 mgExact identifier — unii candidate
15 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / ORAL14 mgExact identifier — unii candidate
32 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKFILM, SOLUBLE / ORAL14 mgExact identifier — unii candidate
15 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, FOR SUSPENSION / ORAL0.1 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET / SUBLINGUAL0.13 mgExact identifier — unii candidate
32 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSUPPOSITORY / RECTAL375 mgExact identifier — unii candidate
6 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XSUSPENSION / ORAL62.5 mg/5mlExact identifier — unii candidate
11 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii candidate
32 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, DELAYED RELEASE / ORAL8.4 mgExact identifier — unii candidate
15 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL, METERED / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KLOTION / TOPICAL1000 mgExact identifier — unii candidate
32 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XSOLUTION / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii candidate
32 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZINJECTION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, EXTENDED RELEASE / ORAL229.7 mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKGUM, CHEWING / BUCCAL3492 mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii candidate
15 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XSUSPENSION / TOPICAL2.15 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS0.02 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / VAGINAL0.05 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZINJECTION, SUSPENSION / SUBCUTANEOUSNAExact identifier — unii candidate
6 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKPOWDER, DENTIFRICE / DENTAL0.5 mg/mgExact identifier — unii candidate
15 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XSUPPOSITORY / VAGINALNAExact identifier — unii candidate
11 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XSPRAY / TOPICAL4.58 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET / ORAL793 mgExact identifier — unii candidate
15 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XTABLET / ORAL4 mgExact identifier — unii candidate
11 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSHAMPOO / TOPICAL0.1 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOAP / TOPICAL0.02 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XLOTION / TOPICAL89 mgExact identifier — unii candidate
11 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / TOPICAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KAEROSOL, FOAM / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSOLUTION / INTRAVENOUS3.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE, LIQUID FILLED / ORAL0.1 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KGUM, CHEWING / BUCCAL5 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION, CONCENTRATE / ORAL0.1 mg/1mlExact identifier — unii candidate
32 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XCREAM / VAGINAL100 mgExact identifier — unii candidate
11 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, COATED / ORAL64.8 mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE, DELAYED RELEASE / ORAL20 mgExact identifier — unii candidate
15 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KFILM, SOLUBLE / ORAL0.06 mgExact identifier — unii candidate
32 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
7f0bdab0-a02e-8afb-e053-2991aa0aa288a9721ef1-daa2-4c25-98ba-81a9965582b52019-01-09WarningsExact identifier
spl id: 7f0bdab0-a02e-8afb-e053-2991aa0aa288
spl set id: a9721ef1-daa2-4c25-98ba-81a9965582b5

Reported adverse events (FAERS/openFDA)#

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