FDA.reportPublic FDA data

Free and Pure Cold Therapy Pain Relief

Manufacturer
Walgreen Co. | Natural Essentials, Inc.
Effective date
2025-06-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:02:50

Label at a glance#

ProductFree and Pure Cold Therapy Pain Relief
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure8 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joing associated with simple backache arthritis strains bruises sprains

Dosage and administration

adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily children under 2 years of age: do not use, consult a physician wash hands after use with cool water

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joing associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only.

Flammable: Keep away from excessive heat or open flame.

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with the yes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritate skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience pain, swelling, or blistering of the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age

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 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily
  • children under 2 years of age: do not use, consult a physician
  • wash hands after use with cool water

Other information

OTHER SAFETY INFORMATION

  • store at 20-25°C (68-77°F)
  • store in a cool dry place away from direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Silicon Dioxide, Tocopheryl Acetate, Water

Principal Display Panel - 8 fl oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens Free and Pure t

Cold Therapy Pain Relief Gel Pump

Menthol 4%, topical analgesic

Compare to the active ingredient in Biofreeze ® Gel tt

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

Soothing menthol

tFree + Pure is:

  • Fragrance Free
  • Hypoallergenic
  • Paraben Free

8 FL OZ (236.5 mL)

Free and Pure LabelFree and Pure Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0383-08Free and Pure Cold Therapy Pain Relief237 mL in 1 BOTTLE, PUMPGEL2374

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
0363-03830363-0383-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
WATER059QF0KO0RIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
AMINOMETHYL PROPANOLLU49E6626QIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ALOE VERA LEAFZY81Z83H0XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT

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
Free and Pure Cold Therapy Pain ReliefMENTHOLWalgreen Co.22cbbffc-f876-411e-e063-6394a90a1b382025-06-12WarningsExact identifier
ndc (package): 0363-0383-08
ndc (product): 0363-0383
ndc11 (package): 00363038308
spl id: 376626f7-0d07-f936-e063-6294a90a3691
spl set id: 22cbbffc-f876-411e-e063-6394a90a1b38

Reported adverse events (FAERS/openFDA)#

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