CVS Hot and Cold Balm

Manufacturer
CVS
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:46:57

Label at a glance#

ProductCVS Hot and Cold Balm
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 7.6%

Methyl Salicylate 29%

OTC - PURPOSE SECTION

Topical analgesic

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with

arthritis

simple backache

muscle strains

sprains

bruises

cramps

WARNINGS SECTION

For External use only

Allergy alert

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use

OTC - WHEN USING SECTION

When using the product

Use only as directed. Read and follow all directions and warnings on this label

Avoid contact with eyes and mucous membranes

rare cases of serious burns have been reported with products of this type

do not apply to wounds or damaged, broken or irritated skin

do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use

do not use at the same time as other topical analgesics

a transient burning sensation may occur upon application but generally disappears in seven days

if severe burning sensations occurs, discontinue use immediately

do not expose the area treated with product to heat or direct sunlight

avoid applying into skin folds

OTC - STOP USE SECTION

Stop use and ask a 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

you experience signs injury, such as pain, swelling, or blistering where the product was applied

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

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

Directions adults and children over 12 years:

apply a thin layer to affected area

massage into painful area until thoroughly absorbed into skin

repeat as necessary, but more than 4 times daily

AFTER APPLYING, WASH HANDS WITH SOAP AND WATER children 12 years or younger: ask a doctor

INACTIVE INGREDIENT SECTION

Paraffin, white petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage LabelPackage LabelPackage Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-999CVS HOT AND COLD BALM (MENTHOL 7.6% METHYL SALICYLATE 29%) CREAM [CVS]5Legacy NDC20241213_d166781d-a506-758a-e053-2995a90a5bc7.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-99951316-999-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
471acd65-abdb-b838-e063-6294a90a9d69d166781d-a506-758a-e053-2995a90a5bc72025-12-29WarningsExact identifier
spl set id: d166781d-a506-758a-e053-2995a90a5bc7

Reported adverse events (FAERS/openFDA)#

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