FDA.reportPublic FDA data

Signature Care Cold and Hot Medicated

Manufacturer
Safeway
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:46

Label at a glance#

ProductSignature Care Cold and Hot Medicated
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure8 sections

Indications and uses

temporarily relieves minor aches and pains of muscles and joints due to arthritis simple backache strains sprains bursitis tendonitis bruises cramps

Dosage and administration

adults and children 12 years and over: apply patch to affected area as needed but not more than 4 times daily children under 12 years: ask a doctor for easy application; partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Menthol - Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains of muscles and joints due to

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

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: apply patch to affected area as needed but not more than 4 times daily
  • children under 12 years: ask a doctor
  • for easy application; partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin.

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer, carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxypropyl cellulose, kaolin, partially neutralized polyacrylate, polyvinyl alcohol, purified water, sorbitol solution, tartaric acid

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Signature Care Cold & Hot Medicated Patch
Signature Care Cold & Hot Medicated Patch

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts
Drug Facts

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
21130-980-012023-04-04C16284748780-1c7ccaba7-2799-fd44-e053-dadaa90aa01bDrug Facts - Signature Care Cold and Hot Medicated
21130-980-012023-01-30C16284748780-1c7ccaba7-2799-fd44-e053-dadaa90aa01bDrug Facts - Signature Care Cold and Hot Medicated
21130-980-012021-10-04C16284748780-1c7ccaba7-2799-fd44-e053-dadaa90aa01bDrug Facts - Signature Care Cold and Hot Medicated
21130-980-012021-07-23C16284748780-1c7ccaba7-2799-fd44-e053-dadaa90aa01bDrug Facts - Signature Care Cold and Hot Medicated

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-980-01Signature Care Cold and Hot Medicated1 in 1 CARTONPATCH14
21130-980-01Signature Care Cold and Hot Medicated5 in 1 POUCHPATCH54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-980SIGNATURE CARE COLD AND HOT MEDICATED (MENTHOL) PATCH [SAFEWAY]4Current NDC, Legacy NDC, 2 package rows20241220_88f59f95-0a7c-458c-949c-0dff16ad94e4.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-98021130-980-01
64032-8125

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
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
CASTOR OILD5340Y2I9GIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
KAOLIN24H4NWX5COIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TARTARIC ACIDW4888I119HIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

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
Signature Care Cold and Hot MedicatedMENTHOLSafeway88f59f95-0a7c-458c-949c-0dff16ad94e42024-12-17WarningsExact identifier
ndc (package): 21130-980-01
ndc (product): 21130-980
ndc11 (package): 21130098001
spl id: 2979f7b4-e798-eb6d-e063-6394a90a0bda
spl set id: 88f59f95-0a7c-458c-949c-0dff16ad94e4

Reported adverse events (FAERS/openFDA)#

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