FDA.reportPublic FDA data

CVS Health Cold and Hot Roll-On

Manufacturer
NATURAL ESSENTIALS, INC.
Effective date
2019-01-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:33:19

Label at a glance#

ProductCVS Health Cold and Hot Roll-On Menthol
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure9 sections

Indications and uses

temporarily relieves minor pain associated with: arhtritis simple backache muscle strains sprains bruises cramps

Dosage and administration

apply a thin layer to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary, but no more than 3 to 4 times daily IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER ask a doctor

Label contents#

Full prescribing information#

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

Menthol 16%

Purpose:

OTC - PURPOSE SECTION

Topical analgesic

Uses:

INDICATIONS & USAGE SECTION

  • temporarily relieves minor pain associated with:
    • arhtritis
    • simple backache
    • muscle strains
    • sprains
    • bruises
    • cramps

Warnings:

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • use only as directed. Read and follow all directions and warnings on this label.
  • rare cases of serious burns have been reported with products of this type
  • do not bandage tightly or apply local heat (such as heating pads) or medicated patch to the area of use
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning sensation occurs, discontinue use immediately
  • do not expose the area treated with product to heat or direct sunlight
  • avoid applying into skin folds.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

Flammable

SPL UNCLASSIFIED SECTION

  • Keep away from fire or flame.

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: adults and children over 12 years:

DOSAGE & ADMINISTRATION SECTION

  • apply a thin layer to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, 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

SPL UNCLASSIFIED SECTION

  • ask a doctor

Other information:

OTHER SAFETY INFORMATION

Store in a cool dry area. Close cap tightly after use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Capsaicin, Deionized Water, Glycerin, Isopropyl Myristate, Propylene Glycol, SDA 40-2 Alcohol.

Principal Display Panel - Cold & Hot Roll-On Menthol 16% Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS
Health™

Compare to the active
ingredient in Maximum
Strength IcyHot®
Pain Relieving Liquid

MAXIMUM STRENGTH

Cold & Hot
Roll-On

MENTHOL 16%

Pain-relieving liquid

  • Long-lasting formula
  • No-touch applicator
  • Dries quickly

Actual Product Size
on Side Panel

2.5 FL OZ (73 mL)

Principal Display Panel - Cold & Hot Roll-On Menthol 16% Box Label
Principal Display Panel - Cold & Hot Roll-On Menthol 16% Box Label

Principal Display Panel - Cold & Hot Roll-On Menthol 16% Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS
Health™

MAXIMUM STRENGTH

Cold & Hot
Roll-On

MENTHOL 16%

Pain-relieving liquid

  • Long-lasting formula
  • No-touch applicator
  • Dries quickly

2.5 FL OZ (73 mL)

Principal Display Panel - Cold & Hot Roll-On Menthol 16% Container Label
Principal Display Panel - Cold & Hot Roll-On Menthol 16% Container Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66902-241-252024-10-09C16284748780-11030e365-3e58-111a-e063-dadaa90a10e2Drug Facts
66902-241-252024-01-30C16284748780-11030e365-3e58-111a-e063-dadaa90a10e2Drug Facts

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66902-24166902-241-25

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CAPSAICINS07O44R1ZMIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALCOHOL3K9958V90MIACT

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
2411dc88-2942-a0c0-e063-6394a90a39b4a94ff07f-3929-429a-9e77-e357b58de7682024-10-09WarningsExact identifier
spl set id: a94ff07f-3929-429a-9e77-e357b58de768

Reported adverse events (FAERS/openFDA)#

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