Indications and uses
Temporarily relieves minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains
Cold Therapy Pain Relief
- Manufacturer
- Walgreen Co. | NATURAL ESSENTIALS, INC.
- Effective date
- 2024-04-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:11:22
Label at a glance#
ProductCold Therapy Pain Relief
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure9 sections
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: consult a physician wash hands after use with cool water
Label contents#
Full prescribing information#
Active ingredient
Menthol 4%
Purpose
Topical Analgesic
Uses
Temporarily relieves minor aches and pains of muscles and joints associated with
- simple backache
- arthritis
- strains
- bruises
- sprains
Warnings
For external use only.
Flammable: Keep away from excessive heat or open flame.
When using this product
- use only as directed
- avoid contact with the eyes or on mucous membranes
- do not apply to wounds or damaged skin
- do not apply to irritated skin or if excessive irritation develops
- do not bandage tightly or use with heating pad or device
Stop use and ask a doctor if
- you experience pain, swelling or blistering oi 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
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 right away.
Directions
- 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: consult a physician
- wash hands after use with cool water
Other information
- store at 20-25°C (68-77°F)
- store in a cool dry place away from direct sunlight
Inactive ingredients
Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana (Arnica Flower) Extract, Boswellia Serrata Extract, Calendula Officinalis (Calendula) Flower Extract, Camellia Sinensis (Green Tea) Extract, Camphor, Caprylic/Capric Triglyceride, Carbomer, FD&C Blue #1, FD&C Yellow #5, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Organic Ilex Paraguanensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, Water.
Principal Display Panel – 74 mL Bottle Label
Walgreens
Compare to the active ingredient
in Biofreeze®
Roll-On††
WALGREENS PHARMACIST RECOMMENDED
Cold Therapy
Pain Relief
MENTHOL 4% / TOPICAL ANALGESIC
Roll On
Cooling Pain Relief
- For the temporary relief of arthritis,
back pain, sore muscles & joints - Soothing menthol
- Paraben free
2.5 FL OZ (74 ml)
Principal Display Panel – 89 mL Tube Label
Walgreens
Compare to the active
ingredient in Biofreeze® Gel††
WALGREENS PHARMACIST RECOMMENDED
Cold
Therapy
Pain Relief
Gel
MENTHOL 4% / TOPICAL ANALGESIC
Cooling Pain Relief
- For the temporary relief of arthritis,
back pain, sore muscles & joints - Soothing menthol
- Paraben free
3 FL OZ (89 ml)
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0356-03 | Cold Therapy Pain Relief | 89 mL in 1 TUBE | GEL | 89 | 1 | |
| 0363-0356-25 | Cold Therapy Pain Relief | 74 mL in 1 BOTTLE, WITH APPLICATOR | GEL | 74 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Cold Therapy Pain Relief
- Menthol, unspecified form
- ALOE VERA LEAF
- ARCTIUM LAPPA ROOT
- ARNICA MONTANA FLOWER
- INDIAN FRANKINCENSE
- CALENDULA OFFICINALIS FLOWER
- GREEN TEA LEAF
- CAMPHOR (SYNTHETIC)
- CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
- FD&C BLUE NO. 1
- FD&C YELLOW NO. 5
- GLYCERIN
- ISOPROPYL ALCOHOL
- ISOPROPYL MYRISTATE
- ILEX PARAGUARIENSIS LEAF
- SILICON DIOXIDE
- .ALPHA.-TOCOPHEROL
- TROLAMINE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-0356 | 0363-0356-25, 0363-0356-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cold Therapy Pain Relief | MENTHOL, UNSPECIFIED FORM | Walgreen Co. | ede15818-5d17-477d-a8be-7b36bb0770a6 | 2024-04-22 | Warnings | 0363-0356-25 0363-0356-03 0363-0356 00363035625 00363035603 f2ea3545-6938-4a13-8969-32f38f3d9fff ede15818-5d17-477d-a8be-7b36bb0770a6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.