FDA.reportPublic FDA data

Walgreens Cold Pain Relief Gel

Manufacturer
Walgreens, Co | Span Packaging Services LLC | Cosmetic Essence, LLC
Effective date
2021-02-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:37:48

Label at a glance#

ProductWalgreens Cold Pain Relief
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

Temporary relief from minor aches and pains of sore muscles and joints associated with • arthritis • backache • strains • sprains

Dosage and administration

• Adults and Children 2 years of age and older: rub a thin film over affected areas not more than four times daily; massage not necessary. • Children under 2 years of age: Consult physician

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Cooling Pain Relief

Uses:

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains of sore muscles and joints associated with • arthritis • backache • strains • sprains

Warnings:

WARNINGS SECTION

For external use only.

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

Sensitive skin

When using this product:

OTC - WHEN USING SECTION

• Avoid contact with the eyes or mucous membranes • Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays, or liniments • Do not apply to irritated skin or if excessive irritation develops • Do not bandage • Wash hands after use with cool water • Do not use with heating pad or device • Store in a cool dry place.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.

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 accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and Children 2 years of age and older: rub a thin film over affected areas not more than four times daily; massage not necessary.
• Children under 2 years of age: Consult physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Blue 1, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water, Yellow 5

Questions or Comments:

OTC - QUESTIONS SECTION

1-800-925-4733

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

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
0363-0864-032024-01-30C16284748780-11030e365-281a-111a-e063-dadaa90a10e2Walgreens Cold Pain Relief Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0864-03Walgreens Cold Pain Relief89 mL in 1 BOTTLEGEL894

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0864WALGREENS COLD PAIN RELIEF (MENTHOL) GEL [WALGREENS, CO]4Legacy NDC, 1 package rows20210206_6518a1e4-0ec0-e3ea-e053-2991aa0abb16.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0864-03ML - Milliliter0363-0864e5bfcae0-639a-43f6-a3d1-e47f41c9113412022-06-06

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-08640363-0864-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FRANKINCENSER9XLF1R1WMIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
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
ba9bdf55-fcbe-317a-e053-2995a90afc236518a1e4-0ec0-e3ea-e053-2991aa0abb162021-02-05WarningsExact identifier
spl id: ba9bdf55-fcbe-317a-e053-2995a90afc23
spl set id: 6518a1e4-0ec0-e3ea-e053-2991aa0abb16

Reported adverse events (FAERS/openFDA)#

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