Careone Cold & Hot Medicated Patch 5ct (Large) ZDP 2020

Manufacturer
American Sales Company
Effective date
2020-04-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:09:42

Label at a glance#

ProductCareOne Cold and Hot
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 analgesic

OTC - PURPOSE SECTION

Uses

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

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 only as directed
  • avoid contact with eyes or 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 for 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 backing 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

alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide

DOSAGE & ADMINISTRATION SECTION

Distributed by:

Foodhold U.S.A., LLC

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

87108A87108A

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN2
420222menthol 0.05 MG/MG Medicated PatchSCD2
420222menthol 5 % Medicated PatchSY2

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
41520-181-052022-01-28C16284748780-1d6a99b39-bfe0-a426-e053-dadaa90af4c2Careone Cold & Hot Medicated Patch 5ct (Large) ZDP 2020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-181-05CareOne Cold and Hot5 in 1 PATCHPATCH52
41520-181-05CareOne Cold and Hot1 in 1 BOXPATCH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-181CAREONE COLD AND HOT (MENTHOL) PATCH [AMERICAN SALES COMPANY]2Legacy NDC, 2 package rows20200506_95fce4e9-2135-730f-e053-2a95a90a11fd.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-18141520-181-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML · Source PDF

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
a2f49334-37d3-ef55-e053-2995a90a74f795fce4e9-2135-730f-e053-2a95a90a11fd2020-04-10WarningsExact identifier
spl id: a2f49334-37d3-ef55-e053-2995a90a74f7
spl set id: 95fce4e9-2135-730f-e053-2a95a90a11fd

Reported adverse events (FAERS/openFDA)#

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