DOSAGE & ADMINISTRATION SECTION
Adults and children over 12 yrs of age: apply to the affected area 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.
CVS Cold and Hot Roll-On
- Manufacturer
- CVS Pharmacy | Pharma Nobis, LLC
- Effective date
- 2023-12-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:05:15
Label at a glance#
ProductCVS Cold and Hot Roll-On
Active ingredientMENTHOL
Label structure9 sections
Label contents#
Full prescribing information#
WARNINGS SECTION
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. A temporary burning sensation may occur after use but normally disappears in several days. If severe burning sensation occurs, discontinue use immediately. If swelling or blistering of the skin occurs, stop use and seek medical attention. Do not expose treated area to heat or direct sunlight.
INACTIVE INGREDIENT SECTION
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate, Propylene Glycol, SD Alcohol 40 (30%Z), Triethanolamine, Purified Water.
INDICATIONS & USAGE SECTION
Temporarily relieves minor muscle and joint pain associated with arthritis, simple backache, muscle strains, sprains, bruises.
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 right away.
OTC - PURPOSE SECTION
Topical analgesic
OTC - ACTIVE INGREDIENT SECTION
Menthol 16%
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast feeding, ask a healthcare professional before use.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69842-399-97 | CVS Cold and Hot Roll-On | 1 in 1 CARTON | LIQUID | 1 | 4 | |
| 69842-399-97 | CVS Cold and Hot Roll-On | 74 mL in 1 CONTAINER | LIQUID | 74 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- CVS Cold and Hot Roll-On
- Cool and Heat Pain Relief
- ISOPROPYL MYRISTATE
- GLYCERIN
- WATER
- (C10-C30)ALKYL METHACRYLATE ESTER
- PROPYLENE GLYCOL
- TROLAMINE
- ALCOHOL
- CAPSAICIN
- MENTHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-399 | 69842-399-97 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| (C10-C30)ALKYL METHACRYLATE ESTER | XH2FQZ38D8 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| CAPSAICIN | S07O44R1ZM | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CVS Cold and Hot Roll-On | COOL AND HEAT PAIN RELIEF | CVS Pharmacy | b8cc578a-be6d-90c0-e053-2995a90a7742 | 2023-12-20 | Warnings | 69842-399-97 69842-399 69842039997 0cf95166-c4ea-954e-e063-6294a90ae29e b8cc578a-be6d-90c0-e053-2995a90a7742 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.