Cold and Hot paim relieving

Manufacturer
CareOne | Product Quest Mfg
Effective date
2018-01-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:03

Label at a glance#

ProductCold and Hot paim relieving CareOne
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

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

Dosage and administration

Adults and children over 12 years: • apply to affected area but no more than 3 to 4 times daily • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER. Children 12 years or younger: ask a doctor

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                               Purpose

Menthol 16%.....................................................Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION


For external use only.
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, broken or irritated skin • if you experience pain,
swelling, or blistering of the skin where an OTC topical muscle
and joint pain reliever was applied, stop using the product and
seek medical attention immediately. These products should not
cause pain or skin damage.
Stop use and ask doctor if • condition worsens • redness is
present • irritation develops • symptoms persist for more than 7
days or clear up and occur again within a few days
Flammable • keep away from fire or flame

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 over 12 years: • apply to affected area but
no more than 3 to 4 times daily • IF MEDICINE COMES IN
CONTACT WITH HANDS, WASH WITH SOAP AND WATER.
Children 12 years or younger: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

 Acrylates/C10-30 Alkyl
Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate,
Propylene Glycol, SD Alcohol 40 (30%), Triethanolamine, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1995464menthol 16 % Topical LotionPSN1
1995464menthol 160 MG/ML Topical LotionSCD1
1995464menthol 16 % Topical LotionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-777-032020-01-31C16284748780-19d75b9d0-c796-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-777-03Cold and Hot paim relievingCareOne1 in 1 CARTONLIQUID11
41520-777-03Cold and Hot paim relievingCareOne73 mL in 1 BOTTLELIQUID731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-777COLD AND HOT PAIM RELIEVING CAREONE (MENTHOL 16.00%) LIQUID [CAREONE]1Legacy NDC, 2 package rows20180110_40ad3ada-5f4f-42c4-9a9c-468c8d5e3de9.zip

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
41520-77741520-777-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
b186f2f0-a184-4e74-8b4f-917292ad055f40ad3ada-5f4f-42c4-9a9c-468c8d5e3de92018-01-09WarningsExact identifier
spl id: b186f2f0-a184-4e74-8b4f-917292ad055f
spl set id: 40ad3ada-5f4f-42c4-9a9c-468c8d5e3de9

Reported adverse events (FAERS/openFDA)#

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