FDA.reportPublic FDA data

Equate Cool and Heat

Manufacturer
Wal-Mart Stores Inc
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:18

Label at a glance#

ProductEquate Cool and Heat
Active ingredientMENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains of muscles and joints due to: simple backache arthritis bruises muscle strains muscle sprains

Dosage and administration

adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Methyl salicylate 30%

Purpose

OTC - PURPOSE SECTION

Menthol - Topical analgesic

Methyl salicylate - Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains of muscles and joints due to:

  • simple backache
  • arthritis
  • bruises
  • muscle strains
  • muscle sprains

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not get into eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with a heating pad or apply external heat

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • skin redness or excessive irritation of the skin occurs
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

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

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

glyceryl stearate, isoceteth-20, poloxamer, purified water, sodium lauryl sulfate, sorbitan monostearate, trolamine

Questions

OTC - QUESTIONS SECTION

Call: 1-888-287-1915

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts
Drug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311500menthol 10 % / methyl salicylate 30 % Topical CreamPSN4
311500menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD4
311500menthol 10 % / methyl salicylate 30 % Topical CreamSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-470-012023-02-07C16284748780-1f386c64a-3336-0266-e053-dadaa90a7c1aDrug Facts - Equate Cool and Heat
49035-470-012023-01-30C16284748780-1f386c64a-3336-0266-e053-dadaa90a7c1aDrug Facts - Equate Cool and Heat

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-470-01Equate Cool and Heat1 in 1 CARTONCREAM14
49035-470-01Equate Cool and Heat85 g in 1 TUBECREAM854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-470EQUATE COOL AND HEAT (MENTHOL, METHYL SALICYLATE) CREAM [WAL-MART STORES INC]4Current NDC, Legacy NDC, 2 package rows20241219_c5ab2426-eeca-4ba4-9f00-7790d2176471.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-47049035-470-01

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
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOCETETH-20O020065R7ZIACT
POLOXAMER 407TUF2IVW3M2IACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
TROLAMINE9O3K93S3TKIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

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
Equate Cool and HeatMENTHOL, METHYL SALICYLATEWal-Mart Stores Incc5ab2426-eeca-4ba4-9f00-7790d21764712024-12-17WarningsExact identifier
ndc (package): 49035-470-01
ndc (product): 49035-470
ndc11 (package): 49035047001
spl id: 2979f7b4-e799-eb6d-e063-6394a90a0bda
spl set id: c5ab2426-eeca-4ba4-9f00-7790d2176471

Reported adverse events (FAERS/openFDA)#

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