FDA.reportPublic FDA data

CVS Health Cold and Hot Roll-On

Manufacturer
NATURAL ESSENTIALS, INC.
Effective date
2024-10-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:53:18

Label at a glance#

ProductCVS Health Cold and Hot Roll-On
Active ingredientLIDOCAINE, MENTHOL
Label structure10 sections

Indications and uses

temporarily relieves minor pain

Dosage and administration

Rub on affected area - repeat 3 to 4 times daily for adults and children 12 or over under 12 consult doctor before use

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain

Warnings

WARNINGS SECTION

For external use only

  • Avoid contact with eyes or mucous membranes
  • Do not apply to open wounds or damaged skin
  • Do not bandage or use heating pad

Do not use

OTC - DO NOT USE SECTION

  • on large areas of the body or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • servere skin irritation occurs
  • Symptoms persist for more than 7 days or clear up then reoccur again within a few days

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

  • Have sensitive skin
  • Are pregnant or breastfeeding

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

Rub on affected area - repeat 3 to 4 times daily

  • for adults and children 12 or over
  • under 12 consult doctor before use

Other information

OTHER SAFETY INFORMATION

  • This product may cause allergic reaction in some individuals. Test on small area before use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Crosspolymer, Aloe Vera Gel 10x, Aminomethyl Propanol, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Deionized Water, Dimethicone, Caprylyl Methicone, Polysilicone-11, Disodium EDTA, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 60, Methylparaben, SDA 40-2 Alcohol, Steareth-21

Principal Display Panel – 73.9 mL Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS
Health ®

Compare to active
ingredients in IcyHot ®
Lidocaine Plus Menthol*

MAXIMUM STRENGTH

Lidocaine concentration
without a prescription ✝

Lidocaine
Pain Relief
Roll-On

PLUS MENTHOL

LIDOCAINE HCl 4%

MENTHOL 1%

  • Safe & effective
  • Fast acting & long lasting
  • Desensitizes
    aggravated nerves

✝Among over the counter
topical analgesics.

Actual Bottle Size
on Side Panel

2.5 FL OZ (73.9 mL)

Principal Display Panel – 73.9 mL Carton Label
Principal Display Panel – 73.9 mL Carton Label

Principal Display Panel – 73.9 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS
Health ®

MAXIMUM STRENGTH

Lidocaine concentration
without a prescription ✝

Lidocaine
Pain Relief
Roll-On

PLUS MENTHOL

LIDOCAINE HCl 4%

MENTHOL 1%

  • Safe & effective
  • Fast acting &
    long lasting
  • Desensitizes
    aggravated nerves

2.5 FL OZ (73.9 mL)

Principal Display Panel – 73.9 mL Container Label
Principal Display Panel – 73.9 mL Container Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66902-156CVS HEALTH COLD AND HOT ROLL-ON (LIDOCAINE, MENTHOL) CREAM [NATURAL ESSENTIALS, INC.]3Legacy NDC20241006_29ebc5dd-9d57-43b4-a7ce-4ea6d8b280cb.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66902-15666902-156-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-20 PHOSPHATE921FTA1500IACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
ISOHEXADECANE918X1OUF1EIACT
POLYSORBATE 60CAL22UVI4MIACT
METHYLPARABEN SODIUMCR6K9C2NHKIACT
ALCOHOL3K9958V90MIACT
STEARETH-2153J3F32P58IACT
LIDOCAINE98PI200987ACTIB
MENTHOLL7T10EIP3AACTIB

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
23a7cdb9-69ea-378d-e063-6394a90a0f0129ebc5dd-9d57-43b4-a7ce-4ea6d8b280cb2024-10-04WarningsExact identifier
spl id: 23a7cdb9-69ea-378d-e063-6394a90a0f01
spl set id: 29ebc5dd-9d57-43b4-a7ce-4ea6d8b280cb

Reported adverse events (FAERS/openFDA)#

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