FDA.reportPublic FDA data

Equate™ Cold Therapy Pain Relieving Gel Topical Analgesic

Manufacturer
Wal-Mart Stores, Inc. | Garcoa, Inc. | SV Labs Toronto Corporation
Effective date
2024-11-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:17:54

Label at a glance#

ProductEquate Cold Therapy Pain Relieving Analgesic
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

Dosage and administration

adults and children 6 years of age and older apply to affected area not more than 3-4 times daily. Children under 6 years of age: Do Not Use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pads or other heating devices

OTC - STOP USE SECTION

Stop use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Flammable

SPL UNCLASSIFIED SECTION

  • keep away from fire or flame

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years of age and older apply to affected area not more than 3-4 times daily. Children under 6 years of age: Do Not Use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, arnica montana flower extract, blue 1, boswellia serrata resin extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, isopropyl alcohol, isopropyl myristate, silica, sodium hydroxide, tocopheryl acetate, water, yellow 5.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-287-1915

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 89 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 79903-021-01

equate™

Compare
to Biofreeze®
active
ingredient*

Cold Therapy
Pain Relieving
Gel

Menthol 4% Topical
Analgesic

  • For backache, muscle
    pain, joint pain
  • Soothing menthol

3 FL OZ (89mL)

Principal Display Panel - 89 mL Tube Label
Principal Display Panel - 89 mL Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN4
415974menthol 0.04 MG/MG Topical GelSCD4
415974menthol 4 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79903-021-012023-02-13C16284748780-1f386c649-dffa-0266-e053-dadaa90a7c1aEquate™ Cold Therapy Pain Relieving Gel Topical Analgesic
79903-021-012023-01-30C16284748780-1f386c649-dffa-0266-e053-dadaa90a7c1aEquate™ Cold Therapy Pain Relieving Gel Topical Analgesic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79903-021-01Equate Cold Therapy Pain RelievingAnalgesic89 mL in 1 TUBEGEL894

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79903-02179903-021-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GlycerinPDC6A3C0OXIACT
Isopropyl AlcoholND2M416302IACT
Isopropyl Myristate0RE8K4LNJSIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
Sodium Hydroxide55X04QC32IIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
Water059QF0KO0RIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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 Cold Therapy Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORMWal-Mart Stores, Inc.ac6c2112-8692-4628-97d8-3a5a9f5097662024-11-18WarningsExact identifier
ndc (package): 79903-021-01
ndc (product): 79903-021
ndc11 (package): 79903002101
spl id: d81fd6ed-53df-4654-ad0b-9fb807605c5c
spl set id: ac6c2112-8692-4628-97d8-3a5a9f509766

Reported adverse events (FAERS/openFDA)#

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