OTC - ACTIVE INGREDIENT SECTION
Active ingredient Purpose
Menthol 10.5%..............................................................Topical Analgesic
Active ingredient Purpose
Menthol 10.5%..............................................................Topical Analgesic
Uses Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains
Warnings
For external use only.
Flammable: Do not use while smoking or near heat or flame.
When using this product • avoid contact with the eyes or mucous
membranes • do not apply to wounds or damaged skin • do not apply
to the irritated skin • do not bandage • wash hands after use with cool
water • do not use with heating pad or device
Stop use and ask a doctor if • condition worsens, or if symptoms
persist for more than 7 days, or clear up and reoccur.
Keep out of reach of children. If accidentally ingested get medical help or contact a Poison Control Center immediately
Directions • Adults and children 2 years of age and older: Apply
to affected area not more than 3 to 4 times daily. • Children under 2
years of age: Consult physician.
Inactive ingredients Alcohol Denat., Arnica Montana Flower
Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf
Extract, Chamomile Recutita Flower Extract, Dimethyl Sulfone, Echinacea
Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate,
Juniperus Communis Fruit Extract, Water
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0041260384721 | GTIN-13: 0041260384721 EAN-13: 0041260384721 GTIN-12: 041260384721 UPC-A: 041260384721 GTIN storage (14 digits): 00041260384721 | label.jpg |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59450-777-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1260-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59450-777-03 | Cold Therapy Pain Relief | 85 g in 1 CAN | SPRAY | 85 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 59450-777 | 59450-777-03 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Menthol | L7T10EIP3A | ACTIB |
| Alcohol | 3K9958V90M | IACT |
| ARNICA MONTANA FLOWER | OZ0E5Y15PZ | IACT |
| CALENDULA OFFICINALIS FLOWER | P0M7O4Y7YD | IACT |
| GREEN TEA LEAF | W2ZU1RY8B0 | IACT |
| CHAMOMILE | FGL3685T2X | IACT |
| Dimethyl Sulfone | 9H4PO4Z4FT | IACT |
| ECHINACEA ANGUSTIFOLIA | VB06AV5US8 | IACT |
| ILEX PARAGUARIENSIS LEAF | 1Q953B4O4F | IACT |
| Isopropyl Myristate | 0RE8K4LNJS | IACT |
| JUNIPER BERRY | O84B5194RL | IACT |
| Water | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|
| ebad0ba6-dd40-4347-ad06-29e9381d0526 | 1b98a3dc-1999-4db1-86e4-b0ab7d9ce808 | 2018-07-12 | Warnings | ebad0ba6-dd40-4347-ad06-29e9381d0526 1b98a3dc-1999-4db1-86e4-b0ab7d9ce808 |
Adverse event summaries are temporarily unavailable. Other product information remains available.